Tighter Restrictions for Drug Approval Around the World Requires a Collaborative Approach


There’s no doubt that the world is shrinking. The availability and marketing of specific drugs and medical devices are no longer confined to specific countries, but are becoming global efforts.  Likewise, today’s firms and their Contract Development and Manufacturing Organizations (CDMOs) are becoming global operations, with different stages of projects often being performed in different countries or offices, to best leverage specific plants, expertise or other resources.

This is fast becoming the case with PCI Synthesis, which was acquired in June by Novacap, a worldwide player in pharmaceutical synthesis and advanced specialties. As an independent subsidiary of France-based Novacap, we became part of a 3000-person company that operates 28 industrial plants and 11 cGMP facilities, along with two R&D centers of expertise in Europe and Asia. This global reach enables us to give our customers access to some of the best facilities and technical expertise across the globe.

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While we have a firm grasp of U.S. FDA regulations and guidelines and cGMP compliance needs, we also now have greater expertise in the local regulatory environments in Europe and Asia.  Being part of a global team allows us to better navigate international regulatory processes to secure product approvals for our U.S.-based sponsors more efficiently; and in turn, we’re able to help our European colleagues more easily understand and work with the U.S. agencies.

More strict requirements are occurring in federal agencies across the globe – especially for generic drugs.  For example, in the U.S., as part of the Generic Drug User Fee Amendments of 2012 (GDUFA), the FDA requires regulatory filing to be completed electronically in order to be more efficient, reduce costs to the government and eliminate manual, error-prone processes. From registering your site to self-identification, all submissions must be done electronically.

European Medicines Agency

Just as the U.S. requires key technical documentation, such as a Drug Master File (DMF); validation reports for analytical methods; and scientific documentation, so too are there similar requirements from the European Medicines Agency (EMA) in Europe.  EMA is responsible for the regulation of food and drug products in Europe; and the drug approval process involves submitting an Investigational New Drug Application (INDA), followed by submission of a New Drug Application (NDA). The applications are reviewed and agency officials examine the drug’s safety and efficacy data before it is approved. EU establishes four different drug approval processes: a centralized procedure, a decentralized procedure; a national procedure and a mutual recognition procedure.

According to a research report from Yale University, however, the U.S. FDA approves drug products or Active Pharmaceutical Ingredients (APIs) in a shorter timeframe than its counterpart in Europe. Co-authors of the report compared review times for new drugs approved by the FDA and the EMA between 2011 and 2015. They classified drugs according to therapeutic areas and “orphan” drugs, which are for rare diseases. The researchers found that the FDA approved more new drugs than EMA — 170 versus 144.

China Food & Drug Administration

The China Food and Drug Administration (CFDA), however, has been slower than the EMA or FDA to approve new drugs, yet it has been working hard to increase the number of applications it reviews. The  CFDA is considering changing its clinical trial approval system to one similar to the U.S.  Under current rules, a drug company must wait for the CFDA’s official go-ahead before beginning a clinical trial. The new proposal, however, would give the agency 60 working days to either reject or question a trial application. Otherwise, the application would automatically be considered a go. According to an article in Fierce Biotech, although the time frame is still longer than the U.S. FDA’s 30-day response window, it is a big step forward compared with the previously estimated average of 195 days.

Common Commitment to GMP, Best Practices

While our business has always been only under the regulatory perspective of the U.S., as part of Novacap, we’re able to provide services for different regulatory zones. And, opportunities are coming both ways. Since adherence to GMP means something everywhere, we’re able to share best practices with our colleagues, in terms of control of cross contamination, raw materials, or cleaning of equipment, and in addition to more expedient approvals, our standards of quality are elevated globally.

As regulatory agencies around the world, share a common goal of bringing safer, more effective drugs to the marketplace, understanding different markets, regulatory requirements and what it takes to secure approval will increasingly become critical to success.  Globally diverse CDMOs that provide unique expertise and understanding, combined with a common commitment to excellence, can go a long way to removing regional borders and expanding commercial opportunities.