Multinational Pharma Wants More from China’s Drug Rules
by Richard Daverman, PhD
ChinaBio Today
After all the hubbub of drug safety and IP protection, China took some major steps in 2007 to reform its regulatory system. In all, China has issued 53 regulations in 2007 that affect drugs, devices and food. But, according to Chen Yang, an attorney from the Beijing office of Sidley Austin, China overlooked three things on multinational pharma’s wish list:
• Defining what constitutes a new chemical entity;
• Assuring confidentiality of submissions for drug regulation;
• Linking drug approvals to patent protection.
Chen Yang made her comments in a public briefing at the New York offices of Sidley Austin.
Most important of these new regs was the drug regulation system that became effective on October 1. The new rules improve transparency by mandating the SFDA to post lists of approved drugs on its website; they require generics to be consistent with their non-generic branded versions in terms of quality, safety and efficacy; and the rules establish a “special approval” process for certain drugs.
Nevertheless, by omitting a definition of what constitutes a new chemical entity, China did not assure multinationals that the data in regulatory submissions would be kept confidential. Yang said further that even if confidentiality had been promised, cases exist in which data had been leaked. As a practical matter, therefore, she warned drug companies to include information only if they can afford for it to become public.
In the third matter, patent linkage, Yang said that companies must include an affidavit stating the new drug does not infringe on any patents. Patent disputes remain outside the jurisdiction of the SFDA, to be settled by the courts. However, if a patent is ruled to be infringed, the SFDA is not currently obligated to revoke market approval. In the previous set of rules, the revocation right was included.
Pharmas also hope the SFDA will adopt rules similar to the Orange Book system of the FDA. The FDA publishes patent information on approved drugs, but a Bolar exemption allows research on a patented product to continue without being a basis for patent infringement litigation. And once a court decides a product is infringing, multinational pharmas would like the SFDA to revoke marketing approval of the offending product.
Yang says that new rules will be promulgated in 2008 to cover good manufacturing practice, drug safety regulation, and device distribution, administration and safety reporting. One question is whether the “special approval” rules for drugs will be extended to imported drugs as well. Under the special approval rules, the process is fast-tracked and pharmas are allowed to revise clinical trial protocol while a trial is ongoing.
Yang said three provisions may be included in a new patent law, expected next year: the Bolar exemption, compulsory licensing if a public health crisis arises, and disclosure of genetic information within a patent application.
Of course, multinational pharmas would also like the patent protection extended, but Yang does not see a high probability of that particular marketing plum.
China will also review the regulation of imported devices next year. It was proposed that all imported devices be inspected, a proposal that has been indefinitely postponed. Ex-China device manufacturers claimed the new rule would cause them hardship and also harm China patients who were in need of the devices. The medical area is one in which China imports a greater dollar of product than it exports.
ChinaBio Today is a regular contributor to BioHealth Investor
______________
ChinaBio Today
After all the hubbub of drug safety and IP protection, China took some major steps in 2007 to reform its regulatory system. In all, China has issued 53 regulations in 2007 that affect drugs, devices and food. But, according to Chen Yang, an attorney from the Beijing office of Sidley Austin, China overlooked three things on multinational pharma’s wish list:
• Defining what constitutes a new chemical entity;
• Assuring confidentiality of submissions for drug regulation;
• Linking drug approvals to patent protection.
Chen Yang made her comments in a public briefing at the New York offices of Sidley Austin.
Most important of these new regs was the drug regulation system that became effective on October 1. The new rules improve transparency by mandating the SFDA to post lists of approved drugs on its website; they require generics to be consistent with their non-generic branded versions in terms of quality, safety and efficacy; and the rules establish a “special approval” process for certain drugs.
Nevertheless, by omitting a definition of what constitutes a new chemical entity, China did not assure multinationals that the data in regulatory submissions would be kept confidential. Yang said further that even if confidentiality had been promised, cases exist in which data had been leaked. As a practical matter, therefore, she warned drug companies to include information only if they can afford for it to become public.
In the third matter, patent linkage, Yang said that companies must include an affidavit stating the new drug does not infringe on any patents. Patent disputes remain outside the jurisdiction of the SFDA, to be settled by the courts. However, if a patent is ruled to be infringed, the SFDA is not currently obligated to revoke market approval. In the previous set of rules, the revocation right was included.
Pharmas also hope the SFDA will adopt rules similar to the Orange Book system of the FDA. The FDA publishes patent information on approved drugs, but a Bolar exemption allows research on a patented product to continue without being a basis for patent infringement litigation. And once a court decides a product is infringing, multinational pharmas would like the SFDA to revoke marketing approval of the offending product.
Yang says that new rules will be promulgated in 2008 to cover good manufacturing practice, drug safety regulation, and device distribution, administration and safety reporting. One question is whether the “special approval” rules for drugs will be extended to imported drugs as well. Under the special approval rules, the process is fast-tracked and pharmas are allowed to revise clinical trial protocol while a trial is ongoing.
Yang said three provisions may be included in a new patent law, expected next year: the Bolar exemption, compulsory licensing if a public health crisis arises, and disclosure of genetic information within a patent application.
Of course, multinational pharmas would also like the patent protection extended, but Yang does not see a high probability of that particular marketing plum.
China will also review the regulation of imported devices next year. It was proposed that all imported devices be inspected, a proposal that has been indefinitely postponed. Ex-China device manufacturers claimed the new rule would cause them hardship and also harm China patients who were in need of the devices. The medical area is one in which China imports a greater dollar of product than it exports.
ChinaBio Today is a regular contributor to BioHealth Investor
______________
posted by Nico at
11:54 PM
0 Comments:
Post a Comment
Subscribe to Post Comments [Atom]
<< Home