China’s law (Implementing Regulations of the Drug Administrative Law) is currently being updated and out for public comments until June 9. The draft regulation includes over 181 articles or over 100 more articles than the current law. Some possible changes among other changes include – 1) now, for pediatric and orphan drugs, there is no market exclusivity; however, in the draft, some pediatric drugs will now have a 12-month exclusivity period, and 7 years for some orphan drugs; 2) currently, chemical drugs (not biologics) have 6 years of data exclusivity for non-disclosed clinical trial data; but now the draft extends the definition of non-disclosed clinical trial data – and also adds other types of data; 3) a new drug is given 5 years of a monitoring duration after approval when the NMPA will not approve the importation or manufacturing of the same drug; however, now the NMPA will terminate the drug monitoring period.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.