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Regulatory Compliance/FDA "The reality is, emerging markets are more complex than they seem on the surface." Joseph Scheeren, senior VP, head of global regulatory affairs and site head of global development Beijing, Bayer HealthCare a paper application slows things down as well. China is expected to move to electronic filings in the near future. The challenges are not just logistical, though. It's also important to remember that medical practices differ worldwide, and that some populations and ethnic groups may metabolize drugs differently. And it's not over once the drug gets to market, either, as the ongoing regulatory requirements are growing globally. For example, if there is a change in labeling in the drug's country of origin, this needs to be updated simultaneously in other countries. MAKING IT WORK PRACTICALLY One of the most practical approaches for managing the different requirements for clinical trials is to work with local partners, and Bayer uses Covance as its preferred partner. The regulatory steps are retained in-house, at one of Bayer's four international hubs (one in the U.S., one in China, and two in Germany). "To get the best out of our partners, and to ensure that everyone is kept aligned, we work closely together, holding regular meetings to discuss issues and exchange best practices," says Scheeren. It's important to know and trust manufacturing partners. This is particularly important, as there have been issues reported in India, China, and the other emerging countries. "There is a new requirement from the EMA for exported products, requiring manufacturers to be certified. The standards for products being exported are quite high, and some local manufacturers are now receiving U.S. and European approval for import," says Scheeren. "China established its first version of GMP in 2000, and implemented the second version in 2010, and the regulatory agencies are validating the manufacturers. Bayer was one of the first to be certified after the 42 LifeScienceLeader.com December 2013 second version. The standards for products being exported are pretty good, and deviations tend to be minor." WHAT CAN WE LEARN FROM EMERGING MARKETS? While the focus has been on what the emerging markets can learn from the West, there is also a lot that the West can learn from the emerging markets, as Scheeren explains. "China's regulatory agency, though small, has achieved a lot. This boils down to a 'can do' attitude, good communication, excellent working relationships, and willingness to work with industry and other regulatory authorities such as the FDA and EMA." LOOKING TO THE FUTURE Moving forward, it will be vital for companies to include Asia and the developing markets in the global development plan, integrating them as much as possible. There have been a lot of changes bringing the requirements and strategies closer to those in Europe and the U.S., but more changes will need to be made to ensure that drugs continue to be developed and marketed with these markets in mind. The FDA has set up offices in many of the developing markets, working to improve overall standards. Benchmarking, collaboration, and cooperation will help to build on this standards effort through formal and informal workshops and meetings. "It would be great to have China completely integrated into a global development plan for most new drugs, but that would need shorter CTAs and simultaneous submissions, not requiring prior U.S. or EU approval," says Scheeren. "However, the trend clearly is in the right direction, and will increasingly lead to earlier access for patients and increased investment from industry."