The Challenge of Staying Current with Regulatory Changes – How one company is providing a solution

Show Notes:

I began the article by asking Ken what prompted WuXi Biologics to begin publishing these regulatory updates. Ken explained that WuXi Biologics works with companies from around the globe in all facets of product discovery, development and GMP manufacturing and across the full drug development continuum from preclinical to commercialization. Due to the nature of the services they provide, they need to provide an optimal regulatory CMC strategy and thus remain up-to-date with the relevant global regulatory expectations. They work proactively to minimize regulatory risks by identifying regulatory changes or new hurdles in advance and thus if needed they can rapidly perform gap analysis and formulate a strong risk mitigation strategy.

We then discussed how having these updates provides a win-win for both WuXi Biologics and their clients. Ken described how the companies that are working with WuXi Biologics are filing INDs and BLAs in various jurisdictions and WuXi Biologics must provide results and documentation that will be a part of those filings. Hence, WuXi Biologics must adhere to the quality and GMP standards required in those various geographic venues.  He went on to say that since they are such a large organization and because they provide a one-stop, single-source development platform it was imperative that they develop an internal mechanism to keep their entire staff up-to-date with the relevant, wide ranging and rapidly evolving regulatory updates and expectations.

I asked Ken about other resources available with regulatory updates. He said that there are other resources available and that they use some of these to help put their update together, but many are not organized by agency and topic. In addition, most and are not as wide-ranging, from a global perspective, as what they felt like they needed for their team. They decided that a quarterly update was just the right size for teams to digest and, if necessary, act on to stay current without disrupting normal daily operations. They thought that offering the translations of relevant NMPA updates and documents would be unique to current industry resources.

Next I asked Ken about whether the updates were just for the regions in which WuXi Biologics has operations – China, Europe and the United States. He clarified that they work with clients to file INDs in many countries around the world not just in the U.S., China and countries currently and formerly governed by the European Medicines Agency or EMA. Some of those other countries include Australia, Korea, Singapore and Japan, thus their updates need to include the regulatory requirements from those countries as well. They also review updates coming from Health Canada, ICH, WHO and PICs amongst others if relevant to biological therapeutics and vaccine development.

I was curious about why they decided to make these updates available to the greater industry. Ken explained that many of the leaders at WuXi Biologics came from drug development companies both large and small from around the globe and they wished that they would have had a similar consolidated and comprehensive update. Ken said that although many larger companies have similar teams assembling this information, many smaller companies do not have the same resources. WuXi Biologics thought that their update would be valuable for them, especially for companies wishing to file in multiple jurisdictions.  They also provide a translated update of the new Chinese regulations, and they believe this provides value to even large organizations looking to bring drugs into the Chinese market place.

I then asked where they have seen these updates provide the most benefit. He said that really it is a means to start a dialog internally or with a client on how a new update or guidance document will impact an organization.  Also being alerted of a new Draft Guidance, especially when a given agency wishes to receive comments from industry, is extremely useful. The more that the industry can provide feedback to regulatory agencies, the more effective the resulting guidance will be. He added that they also use the information from the updates in their discussions and collaborations with clients and partners to ensure everyone is on the same page with global requirements. They are often consulted on how best to file the same product globally in multiple jurisdictions because of their extensive experience and their unique understanding of the China regulatory landscape.

Next we talked about the newsletter’s coverage and whether it was more specific or broad in scope. Ken explained that it was designed to be broad, covering all aspects of biotherapeutics and vaccine drug development, but given the recent impact of COVID-19 and Brexit, they are also providing updates focused specifically to those timely topics. The idea is to keep staff and industry informed of the many relevant regulation updates as they occur. He said, “there is so much information to keep track of, we felt a summary would be useful for specific topics as well.”

I followed up by asking why they chose COVID-19 and Brexit as topics to follow more closely. Ken stated that COVID-19 has a worldwide impact and finding vaccines and treatments is possibly issue #1 for our industry at the moment. This means that regulatory agencies around the globe are continuously meeting and issuing updates and guidance for this initiative. WuXi Biologics is trying to do their part in helping keep people up-to-date. Brexit is more layered and its impact reaches beyond Europe while the EMA is being relocated and the UK breaks away from EMA oversight. This could impact regulatory issues, timing for drug approvals and international relations as well, so they thought it would be good to provide a summary on this critical change.

I asked Ken if there were any caveats to these updates. He said yes, they really only capture updates, guidance documents and regulations that impact biotherapeutics and vaccines. They do not address changes related to medical devices, diagnostics or those updates dealing solely with small molecule drugs. Also, the updates are meant as a tool and another resource for anyone hoping to stay current from a regulatory perspective and should not be construed as regulatory advice nor representing any regulatory agency. Thus, they cannot state that the updates are truly comprehensive of all updates from the regulatory agencies and the updates are for informational purposes only.  In more of a “legal speak” the content is provided “as is” without any warranty.

I closed by asking Ken where we can find the most recent regulatory update and how often it is published. Ken said that they are publishing it quarterly and that it is located on their website where they also keep an archive of past updates. Readers can find updates and sign-up for quarterly updates via email, if they would like at

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