Track changes and comments don’t look consistent when you convert Microsoft Word documents to PDF?

Are you having trouble converting Microsoft Word documents containing track changes and comments to PDF?
Do you continually have to edit the PDF to achieve the desired results?

Creating consistent output when converting MS Word documents containing track changes into PDF is a big challenge. With multiple reviewers and authors working on the same document, each with their styling, getting this consistency is almost an impossible mission

The only way organizations can tackle this right now is manual: changing how the track changes should look like, once authors and reviewers finish editing the document. Considering the large volumes, this is extremely inefficient, slow, and time-consuming. 

It is a manually-intensive process that requires multiple edits in Microsoft Word to get the desired results. 

Force the track changes and comments to look a certain way, when creating PDFs. 

Why not automate this manual PDF editing process and fix inconsistencies much earlier? Why wait to make all these manual manipulations in the PDF document, one by one? Use an automated document conversion solution that can easily ensure consistency in your track changes and comments already from the Word documents. 

Did you know that DocShifter is able to guarantee all track changes and comments appear with a completely consistent look, no matter how the authors and reviewers added them in the original Word document? 

Different options for different scenarios. Do you want the comments to be shown or not? If yes, what style would you prefer: inline changes or in bubbles? All options will be centrally applied when rendering a Microsoft Word document that contains track changes and comments to PDF. Automated, fast, and risk-free.

This consistency ensures you can save valuable time and reduce manual work when sharing content both internally and externally.

About DocShifter

Speed, quality, scalability, and configurability are reasons why Life Sciences organizations choose DocShifter to generate technically compliant, submission-ready PDF. High volume, high-quality document conversion, on-premises, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce risk. Reduce IT infrastructure costs.

Is data taking over the role of PDF in regulatory?

The Life Sciences industry is dedicated to protecting the health of millions of individuals worldwide. The industry is also looking to improve their lives with affordable and easily accessible medicinal products. Patient and patient safety always comes first, which is why the process of bringing a drug to the market takes many years (from 8 to 14 years). 

To be able to launch a product, Life Sciences companies must comply with many regulatory requirements, starting from the first stage of research and product development through initial product commercialization.

Migration from paper-based submissions to e-dossiers

The process of submitting documents to regulatory authorities to receive approval for launching a new medicine dates back to the 1940s. Initially, these submissions were all on paper and consisted of small single-volume dossiers containing fewer than 100 pages. Over time, paper dossiers increased considerably both in complexity and size, making paper-format submissions no longer an appealing option.

The accessibility to information technology and the fast broadband Internet connection changed the way documentation and data were submitted. First introduced in 2003, the eCTD (electronic Common Technical Document) became the expected format for electronic submissions to Health Authorities (HAs) worldwide. 

However, the implementation process of the electronic submissions (both eCTD and NeeS – non-eCTD electronic submissions) by the global HAs took many years and was met with reluctance from the industry. In 2020, there are still 80 countries worldwide that file their submissions on paper. Even China, one of the most technologically advanced countries in the world, is only now implementing the eCTD submission format. Currently, the following countries accept eCTD submissions: the US, EU, Canada, Gulf Cooperation Council (Saudi Arabia, Oman, UAE, Bahrain), Jordan, Australia, Switzerland, South Africa, Thailand, and Japan.

Electronic submissions: PDF submissions vs. Data submissions

Many other countries like China are just now implementing eCTD. To justify all that investment and effort, it will take them years before looking into alternatives to document and PDF submissions. The many regulations make the Life Sciences industry slow moving and understandably risk-averse. Every new process has to be approved, then validated, and finally implemented and this takes up many years.

However, some general discussions about the ongoing implementation process of IDMP (the European regulations on Identification of Medicinal Products) revealed a possible future alternative to the unstructured PDF format. IDMP is an initiative for patient safety and heavily focuses on structured data. Even though it has nothing to do with launching a new product, many companies hope that IDMP will be the beginning of a new era and allow electronic submissions to evolve into data submissions

While there is excellent potential to embrace data submissions, the Life Sciences industry is not ready for such a radical change in today’s reality. Just consider that not long ago, companies used to deliver hard-drives and laptops to the HA where the electronic submissions were stored. This process has evolved gradually over a long period of time, and nowadays, any type of electronic submissions is mostly filed in a PDF format. Given the slow adoption speed and the unrealized potential of eCTD & documents, we believe that PDF will be there for many years to come.

Today’s reality in digital submissions: PDF submissions

There are many reasons why PDF documents are critical for electronic submissions. Let’s take a moment to see what the eCTD stands for: electronic Common Technical Document. This means that in today’s reality, the worldwide expected format for digital submissions is a document, and not data. While that may change in the future, the creation of a new and improved version for the eCTD, namely eCTD 4.0 only comes to support the idea that documents are not going away and that PDF is here to stay.

Another reason why PDF documents are still crucial for electronic submissions is closely related to the huge volumes of documents that are piled up, especially in the first stages of research, development and testing of a new medicinal product. Imagine how many documents a company has after 14 years of research.

When filing for marketing authorization of a new drug, the company must ensure that each and every one of those documents that will be submitted, is technically compliant with the HA requirements. While that is not an impossible task, it is  extremely time-consuming to do it manually and let’s not overlook the increased risk of human error. This is where a solution like DocShifter comes in: automatically converting all those documents into submission ready PDFs for any health authority in the world.

How are the current digital submissions expected to evolve in the future?

Let’s consider the countries that are currently accepting eCTD submissions. As we mentioned before, the Life Sciences industry, due to the risks involved, is very reluctant to change. Therefore, it took decades to move to the electronic PDF format. Additionally, making this change into electronic submissions took a lot of effort and time from both HAs and companies. 

  • On one hand, there are companies that must be able to create the documents in the required eCTD format while being compliant with any additional requirements imposed by each national HA. 
  • On the other hand, there are the HAs that had to implement the technology needed to be able to review the electronic submissions and also train their employees on using the new technology.

Just consider the financial investments of companies and HAs currently accepting the eCTD submissions or are in the early implementation stages. They would have to cover all costs if they were to move to a new, uncertain and not tested format like data submissions.

It is always good to think about new possibilities, and data submissions can become a reality in the future. However, the era of PDF submissions is still here and is not going anywhere for many years to come. There is still a lot of room for improvement in existing submission processes, starting from how compliant PDFs are generated for submissions. 

This is why the Life Sciences industry should focus on the present and search for better ways to optimize their PDF creation processes for electronic submissions. The creation of fully compliant, submission ready PDFs can be much easier, quicker and with less-risk. Multiple compliant PDFs can be generated simultaneously from 1 source document, simplifying the process of submitting the dossier to multiple HAs. 

Even if parts of what is submitted in PDF will become data gradually, it is still years away from becoming the norm.

 

About the author – Paul Ireland 

Paul Ireland - VP Life Sciences - DocShifter

20+ years in helping to provide regulatory software and service solutions to Life Sciences organisations globally. Industry and commercial experience in delivering Content Rendering, Regulatory Information Management, Submission and Report-level Publishing, and Electronic Document Management solutions. 

About DocShifter

Speed, quality, scalability, and configurability are reasons why Life Sciences organizations choose DocShifter to generate technically compliant, submission-ready PDF. High volume, high-quality document conversion, on-premises, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs.

Interested to see how? Check our 30-min. webinar on how modern rendering saves time and reduces risk of non-compliance. See real-life examples from your peers and how Life Sciences companies of any size benefit from modern rendering technologies.

You can easily register below to access the recording.

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Refusal to File (RTF) and how modern rendering can reduce non-compliance risk

Bringing a new medicine or a product to the market is a complex process that typically takes from 8 to 14 years. Although this process may vary from one Health Authority (HA) to another, there are some general stages that the medicine must go through before it can be safely distributed to patients. It starts with research and development (R&D), then slowly moves into the next steps, including assessment and evaluation through non-clinical and clinical trials, filing for marketing authorization to the HA and getting regulatory approval. The final stage is the post-market safety monitoring after the product is launched to the market.

Patient safety is crucial in the Life Sciences industry

There are high risks of taking any shortcuts in this long process. In fact, a study conducted by the Tulane University back in 2003 showed that each 10-month reduction in the US Food and Drugs Administration (FDA) review time period for a new drug can lead to an 18% increase in serious adverse reactions, an 11% increase in drug-related hospitalizations, and a 7.2% increase in drug-related deaths.

Patient safety is the reason why the process of bringing a new drug to the market takes so much time. And since it is the main focus of the entire Life Sciences industry, the new drug can be rejected even before filing for marketing authorization to the HAs if it isn’t considered safe for public use. For example, during the clinical trials, the first phase sees approximately 70% of drugs move to the next step. Phase III trials see only 25-30% of those remaining drugs enter the final stage leading to HA review.

Filing for marketing authorization – is success guaranteed?

Once the drug passes the testing phase, pharmaceutical companies finally reach the stage of submitting a request for authorization to the HA where the drug is going to be marketed. However, there is always a risk of getting a rejection from the HAs.

In fact, research shows that 25% of the marketing applications for drug authorization submitted in the past to the European Medicines Agency (EMA) were rejected. Additionally, looking at the statistics published by the FDA, a total number of 73 refusal-to-file (RTF) letters were issued to non-compliant pharmaceutical companies over a period of 7 years.

One of the main reasons of RTF is the inability to comply with the technical HA requirements.

As explained in one of our previous articles, it takes many years for a new drug to be approved. When the pharmaceutical company is finally able to file for marketing authorization, it must ensure that each document from the millions collected over so many years of research respects all the specific technical requirements from each national HA. This is where an automated document conversion solution like DocShifter can help companies: automatically convert all those documents into submission ready PDFs for any HA in the world and reduce the risk of receiving an RTF.

What are the consequences of receiving an RTF from the FDA?

When a Life Sciences organization’s marketing authorization for a new drug is rejected by the HA for non-compliance, the negative impact can be translated into significant financial losses and damages to the company’s image and reputation. To give you a better understanding of the importance of compliance in the Life Sciences industry, let’s focus on the consequences of receiving an RTF from the FDA.

  1. Fines imposed by the FDA. Under the Prescription Drug User Fee Act (PDUFA), when applying for the approval of a new drug, the pharmaceutical company must pay an application fee (for 2020, the current rates are: $1,471,483 – if no clinical data is required, and $2,942,965 – if clinical data is required). If a drug application is refused for filing, the pharma organization can receive back only 75% of the application fee, incurring financial penalties of $367,871 up to $735,741.
  2. Loss of R&D financial investments. Statistics in the industry show that pharmaceutical companies spend, on average, 17% of their revenue on developing a new drug. This amount translates into an average of $4 billion, and an RTF letter delays (months) in getting the product to market and causing loss of revenue. Even when the company takes actions to become fully compliant with the FDA’s requirements, it will still lose significant amounts of money every day that it doesn’t bring the new drug to the market.
  3. Stock price drops. This is another negative impact that contributes to the significant financial losses incurred after receiving an RTF from the FDA. For example, there was the case with a pharmaceutical company that filed for marketing authorization of its new drug with the FDA in December 2015. Two months later, in February 2016, the company announced that it received an RTF letter from the FDA. Soon after this announcement, the stock prices plummeted by 37.3% in a single day.what can an RTF letter lead to in life sciences? What are the consequences of technical non-compliance? DocShifter
  4. Negative press. Ensuring patient safety is vital in the Life Sciences industry. This means that patients also should be confident in the pharmaceutical company’s ability to bring a new drug to the market that may help improve their lives. If the press discovers that the pharma company’s drug application was refused by the FDA, all that negative buzz can end into losing the customers’ confidence. And when that happens, the consequences can be truly catastrophic and it can really be the end of the new drug, long before being launched to the market.

How can DocShifter help pharmaceutical companies achieve technical compliance?

Pharmaceutical companies can get an RTF for two main reasons: the inability to comply with content requirements (missing information or summaries, appendixes not submitted, etc.) or with technical PDF requirements of that HA. 

Even though there are some tools that can create compliant submission ready PDF documents, they are costly, time-consuming, and have to be manually configured. The DocShifter document conversion software makes sure that your electronic submission documents are fully technically compliant with any HA. Simple, automated, and fast. 

To ease compliance and reduce risk of RTF, DocShifter software provides technical PDF configurations, that are predefined to the technical requirements of each national HA like the FDA (in the US), EMA (in the EU), PMDA (in Japan), HC (in Canada) and many more. With this, every PDF you generate with DocShifter will exactly match what the HAs demand. 

Compliant, pre-defined PDF configurations to create fully technically PDFs for FDA, EMA, PMDA, HC and many more. Save time, reduce risk of non-compliance with DocShifter

Discover more

 

About the author – Paul Ireland 

Paul Ireland - VP Life Sciences - DocShifter

20+ years in helping to provide regulatory software and service solutions to Life Sciences organisations globally. Industry and commercial experience in delivering Content Rendering, Regulatory Information Management, Submission and Report-level Publishing, and Electronic Document Management solutions. 

 

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How to take PDF Rendering to warp speed in 2020

Introduction

Compliance is never far away in the Life Sciences industry. The different health authorities across the globe have set out very specific guidelines when it comes to providing documentation and data. For the right reasons. Life Sciences (pharma, biotech and medical devices) companies spend time and effort to ensure that the information supplied meets these requirements. Not an easy task, as documents live in different systems, versions, digital file formats etc. And that is where standardization comes in. The transformation to a neutral, generally recognized file format such as PDF plays a big role here.

During the entire product life cycle in Life Sciences, PDF files (amongst other formats) are created. PDF ensures consistency, helps to standardize across different departments and platforms. Thus, it helps increase efficiency in document centric processes.

The conversion of different file formats to PDF is often also referred to as ‘document rendering’. Converting documents is generally handled by very specific applications & systems, the so called ‘rendition engines’. This ensures the transformation of one digital file format into another, f.e. PDF.

Document rendering can be done in different ways. The most common approaches are:

  1. By making use of the ‘authoring’ application that was used to author the original document (Microsoft Word, OpenOffice, Microsoft Excel, etc.)
  2. Standalone document rendering, without using the authoring application(s).

Both approaches are very different, and vary greatly in terms of speed, quality, configurability. This article further explains the inherent differences of both. 

Rendering through the use of the authoring application (f.e. Office, Adobe, …)

This approach is being used today by most organizations and is the most common way of creating a PDF. As an example, this is what happens during a Word to PDF conversion with this approach.

  1. The first step is to retrieve the Word file from where it resides. Within large organizations, content can be stored in multiple places: Document Management Systems (DMS) such as: OpenText Documentum, Veeva, Microsoft SharePoint, Box, Alfresco, Generis CARA, Hyland etc. 
  2. The rendering engine connects to the existing Document Management System(s) and pulls the original Word file from there. Or the file is being sent over.
  3. The rendering engine then calls the authoring application (for a Word file, the authoring application is Microsoft Word. For PowerPoint, is Microsoft PowerPoint etc.) to open the original source file.
  4. Subsequently it performs a Print to Postscript action using an Adobe Distiller or other printer driver. 
  5. The rendering server then starts Adobe Distiller or equivalent and the Postscript file loaded, which is then converted to PDF. 
  6. All authoring and Adobe applications are finally closed, and the PDF is sent back to the Document Management System(s). 
  7. The PDF file is stored as a rendition to the original Word document or as a new object. 
  8. The process then repeats for the next Word file.

PDF conversion

So far, so good. The conversion of a Word file to PDF through the authoring application. But, what happens in reality?

” Rendering by using the authoring application
introduces risks.”

Based on the conversations with industry experts, and our customers, this approach has drawbacks:

  1. The authoring applications (Office and Adobe tools and everything else) need licenses. And these come at a price. The number of documents to be converted and the organization size impacts licensing cost. All these authoring applications must also be upgraded, patched and validated. All in all, this brings big (and often overlooked) costs for most organizations. Especially when you consider how many different formats should be converted to PDF. (PowerPoint, Excel, Word etc.)
  2. Rendering through the use of the authoring applications introduces risks. A simple version difference (Word version installed on the desktop vs. Word version installed on the rendition server) can cause all PDF conversions to fail, potentially bringing the entire process to a stop. In some cases, Word documents containing specific settings, have caused the rendition server to inherit these settings, causing incorrect renditions.
  3. Rendering through the use of the authoring applications is slow and burdensome: For every PDF conversion request, the authoring application opens the source file(s). This process, multiplied by thousands of documents for each submission package, can add up to weeks or longer.

Document conversion is being used by many departments (marketing, HR, labelling, regulatory etc.) throughout a large organization. A slow or failed conversion process quickly becomes very costly

Time to market is critical, so coming up with solutions to the above challenges is key.  PDF conversion should be easy, automated and as cost-efficient as possible.

‘’Rendering through the authoring applications is risky, expensive and slow. Is there a more efficient way?’’

Standalone document rendering

There is. DocShifter doesn’t need any authoring applications to perform PDF or any other conversions. Thanks to this architecture, our customers see a 66% cost reduction in IT infrastructure. (licensing, number of servers etc.) Risks associated with authoring applications (slow conversions, extra costs, manual interventions etc.) are simply eliminated. 

PDF conversion

Moreover, DocShifter doesn’t need any authoring applications to run. This significantly improves the conversion speed: 10x faster than comparable solutions.

Docker container technology further empowers the document conversion capabilities of DocShifter. When organizations have the pressure to convert thousands or millions of documents in a very short amount of time, peak loads are easily dealt with.

DocShifter’s standard configurations for FDA, PMDA, EMA and other health authorities allow consistent and automated submission-ready PDF creation. In one go. 

Thanks to native integrations and open API’s, DocShifter connects with any DMS or RIM system. This open connectivity greatly reduces the risk and increases the efficiency, as content is stored in multiple repositories. Document conversion is centralized in 1 platform, for all departments. 

 

About the author – Paul Ireland 

Paul Ireland - VP Life Sciences - DocShifter

20+ years in helping to provide regulatory software and service solutions to Life Sciences organisations globally. Industry and commercial experience in delivering Content Rendering, Regulatory Information Management, Submission and Report-level Publishing, and Electronic Document Management solutions. 

About DocShifter

Speed, quality, scalability, and configurability are reasons why Life Sciences organizations choose DocShifter to generate technically compliant, submission-ready PDF. High volume, high-quality document conversion, on-premises, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs.

Interested to see how? Check our 30-min. webinar on how modern rendering saves time and reduces risk of non-compliance. See real-life examples from your peers and how Life Sciences companies of any size benefit from modern rendering technologies.

You can easily register below to access the recording.

modern rendering

DocShifter 6.3 is rocking rendering again with new and improved functionality

DocShifter 6.3 was born as a result of our development team’s hard work. This release is very special to us, not only because it adds up to industry leading rendering capabilities but also because of how it was built. 6.3 was built completely remotely, as entire team was working from home. Impressive work.

DocShifter 6.3 focuses on improving ease of use, end user communications, administration, and performance. We are happy to share the highlights with you.

Improved end user satisfaction

  • Allow for direct communication between the authors of the content and the status of their transformations. Email notifications can now be sent to the individuals that requested the rendition and/or the user that last checked the document in.
  • Improved handling of Excel, text and PDF/A based files. Defining page sizes and punctuation characters plus more automated encoding detection as well as ensuring complete accuracy to the desired PDF/A compliance level.
  • Enhanced handling of grouped bookmarks reduces the time needed in manual formatting of the results.
  • Better workflow handling of Virtual Documents where concatenated renditions are required. Integrate Virtual Document processing- which was first introduced in DocShifter 6.2.5- into your more complex workflows.

Improved administration

  • Quickly and easily view the status of all your workflows and allow for instant enabling/disabling from the workflow list. This improves the general usability in a production environment.
  • Export all your workflows at once, saving time with upgrades & migrations.
  • Easily identify which configuration parameters are mandatory, saving time when setting up new workflows.
  • Easily identify which DocShifter server (where multiple servers are in use) an email notification was sent from. Speed up your error investigation processes.

Additional improvements have been made to increase performance and handling of the huge quantities of diverse content DocShifter is expected to process on a daily basis. Please refer to the release notes available on the customer portal for full details of this exciting new release.

Stay tuned for the release of our new Table of Contents module in the coming weeks.

About DocShifter

Speed, quality, scalability, and configurability are reasons why Life Sciences organizations choose DocShifter to generate technically compliant, submission-ready PDF. High volume, high-quality document conversion, on-premises, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs.

Interested to see how? Check our 30-min. webinar on how modern rendering saves time and reduces risk of non-compliance. See real-life examples from your peers and how Life Sciences companies of any size benefit from modern rendering technologies.

You can easily register below to access the recording.

modern rendering

PeopleScout significantly improves efficiency and speed in document and PDF conversion with DocShifter

PeopleScout Technology, a world leader in recruitment process outsourcing (RPO) has recently chosen DocShifter to convert all incoming digital formats to high quality PDF files. System administrator Chris Bellgard explains the impact of this decision at PeopleScout with numbers.

How did automated document and PDF conversion impact Chris’ daily activities at PeopleScout?

Would you like to improve your document conversion?

Schedule a demo

 

DocShifter powers the document conversion solution in Generis new CARA cloud offering

We are happy to announce our DocShifter software will be the default enterprise document conversion solution in Generis’ new CARA cloud offering. The integration will further strengthen the bond between organizations and allows the new CARA to serve a larger range of clients with expanded document conversion functionalities.

New CARA cloud offering provides an enterprise content and information platform, able to store and manage data both in CARA as well as that stored in a range of other repositories.  While the integration has been available for classic CARA for some time, it will now be the default option for the New CARA Cloud platform for customers requiring rendering meeting a range of complex requirements of regulated industries. 

DocShifter solution automates any-to-any conversions with support for 300 input and output formats. The speed, scalability and connectivity with all DMS & RIM systems make DocShifter technology an essential for Life Sciences organizations that deal with complex content and document conversion requirements. 

 “With the integration of DocShifter as the default document conversion solution into the new CARA, we are able deliver our promise even better: drastically speeding up and simplifying the complex process of content and document conversion. DocShifter’s document conversion capabilities, combined with new CARA, are able to answer the complex requirements of highly regulated industries,” states Geert van Peteghem, CEO of DocShifter. 

“We already support many joint customers who have advanced document conversion requirements met by the integration of DocShifter with CARA,” said James Kelleher CEO of Generis. “We are now happy to be able to offer this on a pre-built package with New CARA on our cloud for such customers.”

About DocShifter

DocShifter

DocShifter was created in 2007 to respond to the need for easy and fast content conversion in highly regulated environments. Customers can be found worldwide in Life Sciences, Public Sector, Engineering, Banking & Insurance. The company is headquartered in Ghent, Belgium.

At DocShifter, we believe that relevant digital content should never become obsolete. Unstructured information needs to be kept in a readable and searchable format, for generations to come. In our fast-paced digital world, standards appear and disappear. Transforming all this digital content, in whatever shape or form is our goal. To ensure your information continues to provide value.

About Generis 

Generis is a global leader in content and information management systems, specialising in proven solutions for regulated industries. Established in 1997 as a consultancy group, Generis has since grown and developed alongside its flagship product CARA. Our mission is to provide a platform which is highly configurable and user friendly; a dedicated team works hard to guarantee customer satisfaction. Currently counting over 450,000 users across numerous industries worldwide, including 8 of the 10 largest Life Science companies, CARA continues to progress to become the answer for end-to-end data management. 

To find out more visit: www.generiscorp.com

About DocShifter

Speed, quality, scalability, and configurability are reasons why Life Sciences organizations choose DocShifter to generate technically compliant, submission-ready PDF. High volume, high-quality document conversion, on-premises, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs.

Interested to see how? Check our 30-min. webinar on how modern rendering saves time and reduces risk of non-compliance. See real-life examples from your peers and how Life Sciences companies of any size benefit from modern rendering technologies.

You can easily register below to access the recording.

modern rendering

Successful eCTD Implementation in China: 3 Lessons Learned

China is the most populous country on the planet accounting for more than 18% of the world’s population. Following the focus placed on biopharmaceutical development by the Chinese government in the last decade, the country’s global industry ranking rose from 9th largest in 2007 to 2nd in 2017. 

To help expedite the review and approval of new medicines, China will soon join other Asia Pacific countries in accepting submissions in a fully electronic eCTD format. The implementation of eCTD in Japan and Thailand highlighted many hurdles for both domestic and international biopharmaceutical companies, some of which can be avoided.

CFDA eCTD Adoption

After joining the ICH (International Conference on Harmonization) in June 2017, China’s draft eCTD guidance has now been provided by the CFDA (China Food & Drug Administration). It is time for any organisation looking to gain approval for their products in the Chinese market to prepare to take advantage of this regulatory change.

  • eCTD approach.
    • The CFDA is adopting the ICH specification 3.2.2. This means it will more closely follow the US FDA’s submission process rather than the European EMA’s implementation (or the Japanese PMDA with its unique approach to lifecycle).
    • Clinical trial datasets and Study Tagging Files (STF) will be required and node extensions will not for example.
  • Chinese language usage.
    • Documents will be required in Chinese with English versions as reference.
    • eCTD leaf titles will also be required in Chinese.
  • Review and validation.
    • Submissions are expected via CD/DVD delivery initially with an electronic gateway in the future.
    • A link is expected from the CDE (Centre for Drug Evaluation) website which will allow for free submission validation (they will be using LORENZ (member of the Alliance of Experts) technology for their own validation, review and management).

Top 3 considerations when implementing eCTD in China.

  1. Thoroughly review all supporting technology required.
    • Review whether a new publishing solution is required to deal with the specific Chinese eCTD needs. A solution that was ideal for EU and US submissions may no longer be the preferred platform once Chinese conditions are added. As an example, companies often used different tools for Japanese submissions, because of their unique requirements. Consolidating on common tools, however, provides huge efficiencies and savings across global regulatory teams.
    • Ensure a rendering platform that can convert all required original source content into fully technically ICH-compliant PDF files is in place, and that multi-byte Chinese character sets are well handled. Many companies un-necessarily continue to struggle to implement a single consistent platform that handles the needs of both Asian and Western character sets. Most often, local tools are used to ensure the converted content meets the local technical submission guidelines.
    • Ensure all supporting content creation, management, manipulation, publishing and validation technologies support the multi-byte Chinese documents which will be used.
    • Thoroughly test all solutions in as close to real world conditions as possible (use pilots where possible).
  2. Understand the cultural requirements as well as the technical requirements.
    • Flexibility is required to account for different interpretations of ‘recommendations’ in any guidelines. While Japanese companies, for example, typically strictly adhere to all rules including any recommendations, companies in the US might choose not to follow some recommendations where particular efficiencies might be gained by not doing so. A similar understanding of the Chinese approach in these situations is essential to a successful implementation of eCTD.
    • Having a partner based in China or with a very deep understanding of the Chinese regulatory culture is critical to success. As with any region, historical and cultural knowledge when dealing with the local authority can be critical in ensuring a timely submission process.
  3. Ensure teams affected are thoroughly trained.
    • eCTD provides significant benefits, but the tools and processes require a great deal more training than most companies allow for.
    • Start training early. Training should begin well before the first submission in eCTD to China is planned.
    • Get involved with any pilots should there be any. This provides the best way to test your systems and internal processes prior to a live submission. Ensure you test lifecycle updates as well as the initial 0000 submission. You will receive invaluable feedback no matter how well organised you are.

Conclusion

With such a huge quantity of applications being received, the implementation of eCTD will certainly help provide a timelier review process and continue to help alleviate the backlog of work for the CDE. 

REVIEW RESULTS                                       .
APPLICATION TYPE APPROVED REFUSED OTHER TOTAL
IND 554 12 37 603
Confirmatory clinical trial 130 14 96 240
NDA 132 9 65 206
ANDA 1038 115 1200 2353
Supplementary application 1776 127 511 2414
Import re-registration 395 27 60 482
Generic drug QCE / 238
Re-review / 88
TOTALS 4,025 304 1,969 6,624
Chemical drugs reviewed by CDE in 2018

 

Since the initial release will not mandate the use of eCTD, this transition period provides biopharmaceutical companies with the opportunity to avoid some of the headaches they faced when adjusting their processes for other regions. Supporting technologies have also evolved since eCTD was first introduced to the global stage and harnessing some of these can further ease this evolution in China.

DocShifter supports the transformation of content into formats required by the CFDA and other regulatory health authorities.

You can download the PDF version of this article via the link below.

Download the PDF

About the author – Paul Ireland 

Paul Ireland - VP Life Sciences - DocShifter

20+ years in helping to provide regulatory software and service solutions to Life Sciences organisations globally. Industry and commercial experience in delivering Content Rendering, Regulatory Information Management, Submission and Report-level Publishing, and Electronic Document Management solutions. 

About DocShifter

Speed, quality, scalability, and configurability are reasons why Life Sciences organizations choose DocShifter to generate technically compliant, submission-ready PDF. High volume, high-quality document conversion, on-premises, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs.

Interested to see how? Check our 30-min. webinar on how modern rendering saves time and reduces risk of non-compliance. See real-life examples from your peers and how Life Sciences companies of any size benefit from modern rendering technologies.

Find the video on our YouTube channel.

modern rendering

6 Valuable Tips: Why should you convert to PDF?

Most companies are not demanding when it comes to the file formats they use. They just use the most common file formats as the logical extension of their software tools. The best example is the Microsoft Office package. Although Word is a good program for word processing, text editing and file formatting, a Word-file (.docx) is not the best suited file format for storage, archiving, sending sensitive and private data, and internet sharing purposes. Read more

How Docker puts your rendering farm on steroids

Infinite scalability in document conversion through container technology

Container technology* has been around for a while now. The benefits are clear: scalability, rapid deployment, cost savings, simplicity. In 2019, 78% of all companies have moved workloads to containers, according to a study by DivvyCloud.

Containerization has now come to the advanced rendering space. In this blog post, we focus on the use cases and advantages of running advanced rendering on Docker. 

*Container technology is a method to package an application so it can be run, with its dependencies, isolated from other processes. A container is a package that includes everything to run an application. Containers rely less on external hardware and software and can run on any environment (Microsoft, Linux, Mac etc.)DocShifter and Container (Docker) technology for infinite scalability and easier deployment

Why should you investigate running your rendering farm on Docker?

Document conversion is a resource intensive process. Moreover, the workload is highly unpredictable in most cases. And there is typically considerable time pressure. 

Think of thousands:

– of ICH compliant PDF files that need to be generated at submission time in Life Sciences. 

– of payslips that need to be sent at the end of the month. 

– of documents that are flowing into the organization, that need standardization/harmonization before being added to a content repository.

Today, most companies have architected their solution for peak loads. They have built huge rendering farms for doomsday. And these sit idle most of the time. Resulting in an IT architecture that is largely overscaled, expensive and inefficient.

DocShifter on Docker - Ultra scalability at lower cost

With DocShifter implemented on Docker, you can scale when you need to. When your business requires it. It gives you the ability to spread your workload over as many resources as needed.

Scalability taken to the next level. Effiency²

When we designed DocShifter years ago, it was already designed with maximum scalability in mind. Our customers can scale, by adding additional transformation engines, or receivers.

DocShifter on Docker takes this scalability to the next level.

With DocShifter implemented on Docker, you can scale when you need to. When your business requires it. It gives you the ability to spread your workload over as many resources as needed. Eliminating the costs related to setting up and maintaining an oversized rendering farm

DocShifter architecture automatically starts as many transformation engines as necessary to support your business. And it is the transformation engines, or receivers, that takes care of the heavy lifting. 

Combining the speed of DocShifter with the efficiency of Docker puts your rendering farm on steroids. Effiency². Thanks to the nature of Docker, fewer hardware and software resources are needed to run the same application. DocShifter on Docker allows organizations to save big.

This setup allows for true transversal services for content transformation – serving multiple departments within your organization. Centrally.

Automate deployment

You decide where you run your content transformation operations: on-site, in a private cloud, a hybrid cloud or in a public cloud. If it runs on your system, it runs everywhere. 

With DocShifter on Docker, combined with Kubernetes – you can automate your deployment, scaling and operations of content transformation containers across clusters of hosts. With DocShifter, you get all the benefits from running Infrastructure as Code: time saving, cost saving – and reduced risk!

Discover More     Schedule a demo

About DocShifter

Speed, quality, scalability, and configurability are reasons why Life Sciences organizations choose DocShifter to generate technically compliant, submission-ready PDF. High volume, high-quality document conversion, on-premises, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs.

Interested to see how? Check our 30-min. webinar on how modern rendering saves time and reduces risk of non-compliance. See real-life examples from your peers and how Life Sciences companies of any size benefit from modern rendering technologies.

You can easily register below to access the recording.

modern rendering

Last update: 08/01/2021