On July 31, 2015, the China Food and Drug Administration (CFDA) published a draft policy paper for public comments by August 15, 2015, proposing new initiatives to resolve its current review backlogs, and to improve and reform its drug review systems. A few highlights are:
- CFDA will raise its technical standards to review generic drug applications process and focus more on quality and efficacy equivalence. Among all pending generic drug applications, CFDA may deny those applications if the manufacturers fail to prove such equivalence with the innovative drugs that are already available in China; for those pending generic drug applications of which the innovative drugs are not yet available in China, CFDA may approve the applications using its current review standards, on the condition that the manufacturers must prove such equivalency within three years.
- CFDA will closely scrutinize drug applications which involve change of dosage form, change of route of administration, etc. Except for pediatric drugs, CFDA will not approve such drugs unless manufacturers can prove they are innovative, safe, effective and have apparent advantages over the previous dosage forms. In addition, CFDA may not approve those generic drugs with (i) less market demand, (ii) unspecified active ingredients, unclear structures and uncertain efficacy; (iii) potential safety risks and (iv) unreasonable dosage forms, and will develop a list of such products.
- CFDA will optimize its review of clinical studies by focusing more on protection of study subjects. In particular, bioequivalence tests, which are currently treated as clinical studies for CFDA review purpose, will no longer be subject to a clinical trial approval, but rather a filing with CFDA.
- CFDA will expedite its approval of drugs with urgent clinical needs. A separate queuing system will be created for review of pediatric drugs and drugs that are under parallel applications in the United States and the EU.
- CFDA will also expedite its review and approval of pending applications for drugs that have an urgent clinical need and whose patents are soon to expire. Further, for drugs protected by Chinese patents, CFDA will not accept any clinical trial application for a generic until six years before patent expiration, or any manufacturing applications for a generic until two year before patient expiration.
These new initiatives, if eventually finalized, would be greatly beneficial to innovator drug manufacturers in terms of review timeline and criteria, with improved patent protection. However, some of these initiatives might need to be endorsed by the national regulations or by revising existing regulations of CFDA.
If you have any questions regarding this Sidley Update, please contact the Sidley lawyer with whom you usually work, or
| Ling Su
Strategic Advisor, Life Sciences
To receive Sidley Updates, please subscribe at www.sidley.com/subscribe.
Sidley Austin provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship.
Attorney Advertising - For purposes of compliance with New York State Bar rules, our headquarters are Sidley Austin LLP, 787 Seventh Avenue, New York, NY 10019, 212.839.5300; One South Dearborn, Chicago, IL 60603, 312.853.7000; and 1501 K Street, N.W., Washington, D.C. 20005, 202.736.8000.