China gets ready to launch eCTD, as companies face a challenging learning curve

by Winnie Yang and Leslie Wan

China is gearing up for the implementation of electronic Common Technical Document (eCTD) submissions to accelerate the review and approval of new pharmaceuticals. A year after officially introducing the subject, the life sciences industry in this country is starting to see greater momentum toward implementation.

Publication of official specifications is expected in late May, and the China Food and Drug Administration (CFDA) could start accepting eCTD submissions from companies as early as the second half of 2019. Once adopted, China will become the third country in Asia to implement the eCTD, after Japan and Thailand.

The eCTD ultimately benefits pharmaceutical companies. It results in expedited reviews, which in turn means faster approvals and faster time to market. For the regulatory authorities, eCTD enables more efficient review processes. Reviewers can access the information they need more easily and quickly get back to the company if they have a question.

Gaining experience

There is, however, a learning curve, and most Chinese pharmaceutical companies have limited, if any, experience with the eCTD. While some Chinese companies have submitted eCTDs to European or U.S. agencies, it’s likely they used a vendor or affiliate to help them with the process.

As Chinese pharmaceutical companies consider establishing their own internal teams to manage the eCTD process, they will need to plan carefully. First, those regulatory teams will need to gain experience with eCTDs. Over the past 2 years, a number of training courses were offered in China on how to prepare an eCTD. But few are familiar with the detailed requirements for eCTD submissions.

Another challenge for Chinese pharmaceutical companies is building the right team. In U.S. and EU companies, regulatory operations teams usually handle submissions, leaving regulatory affairs to manage more strategic activities.

Many Chinese pharmaceutical companies have only regulatory affairs teams. But with the onset of eCTD, these teams will find it daunting to take on the dual roles and responsibilities of tasks traditionally assigned to regulatory operations teams. Indeed, once they become familiar with the detailed specifications of the eCTD, the regulatory affairs teams are finding it’s not a simple task. It’s not just about managing the granular structure and dossier compilation but also how to appropriately write the documents and effectively apply hyperlinks and bookmarks to help the health authority reviewer navigate through an application quickly and efficiently. Regulatory teams need to become comfortable with writing and building documents, dealing with the granularity required and establishing processes, as well as preparing the software, training their teams and even finding the right employees to handle these tasks.

Being prepared

The period from publication of the specifications to acceptance of an eCTD to, eventually, the eCTD becoming mandatory, presents a good opportunity for Chinese companies to develop their expertise and build their eCTD partnerships. The eCTD provides the regulatory landscape with greater consistency and harmonization. But while it is a positive change for China’s regulatory community, it will also require a period of adjustment and learning for all. This includes the agency, which will need time to bring in software, validate it, and become comfortable with the tools and processes.

There’s a lot of work for both companies and regulators to do in becoming eCTD ready. It will be imperative to gain expertise with the eCTD or work with an experienced partner that can share best practices and staffing expertise. Regulatory departments can make their jobs easier by staying on top of the guidance changes as CFDA regulators finalize the documentation.

Another important step will be to assess the company’s readiness for eCTD from a people, process and tools perspective to identify gaps. The earlier those gaps are addressed, the easier it will be to ensure that the company is in a position to comply with the new regulations.

The time is now to be ready ahead of any eCTD mandate and to avoid the risk of scrambling to meet regulatory requirements.


Winnie Yang is the Head of Life Sciences Business Process Services China Operations at DXC Technology. She oversees a team of 100 employees, supporting various local and global pharmaceutical companies with their regulatory needs. Our China office is one of three Centers of Excellence working in concert to provide a “follow-the-sun” workflow between multiple time zones. Winnie received a Bachelor’s degree in International Finance from Tianjin Foreign Studies University and a Master’s in Business Administration from Nankai University.

Leslie Wan is the Global Head of Presales for Life Sciences Business Process Services Regulatory Submission Services at DXC.  She has been working in the pharmaceutical arena for 12 years. DXC’s BPS Regulatory Publishing Services are designed to take cost out of drug development while also speeding the time it takes to get a drug approved for sale. Leslie graduated from Binghamton University with a Bachelor of Science in Biochemistry and has a Masters in Toxicology from St. John’s University.

 

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