Global Insight Perspective | |
Significance | China will redouble its efforts to re-register 100,000 of the 170,000 products on file with regulator the SFDA. |
Implications | The move comes amid growing concerns over the quality of medicines in China and further changes to drug registrations planned for later this year. |
Outlook | Large foreign firms are not expected to be affected, but registrations for non-existent drugs and applications by distributors are expected to be revoked. Important differences between registrations filed under older and more recent regulations should be at least partially eliminated. |
Interfax reports that Chinese drug regulator the State Food and Drug Administration (SFDA) is to resume plans to revise drug registrations at a time of mounting concerns over the safety and quality of medicines. SFDA registration chief Zhang Wei has remarked that around 20,000 reviews will be conducted, giving mid-2008 as his ambitious target date for completing the process. Provincial regulators will work on the re-registration documentation all year, while the SFDA will aim to complete all outstanding factory inspections by April.
The task of rehabilitating China's medicines market will be huge. An earlier report claims that around 100,000 registrations could be affected—which is a large slice of the 170,000 food and drug products registered in China. This very large figure includes an unknown number of products previously filed with provincial regulators and re-registered with the national SFDA, as well as non-therapeutic foodstuffs registered as drugs. It also includes registrations for products that have never been manufactured or marketed, either by distributors or originators.
The Urge to Purge
China's drive to purge its databases of suspect drug registrations owes much to recent history. It is widely reported that there is growing concern among China's trade partners over product quality issues (see China: 27 February 2008: SFDA Says Foreign Firms Import Chinese Drugs At Their Own Risk). Aside from these concerns, the drive to expunge dubious registrations owes much more to the legacy of uncertainty left by revelations of corruption within the SFDA last year. Months after the execution of disgraced former SFDA chief Zheng Xiayou in July (see China: 29 May 2007: Former Chinese SFDA Chief Receives Death Sentence), the agency announced a review of all registrations which occurred during Zheng's tenure and which may have been obtained through corrupt practices. Officials decided that all drugs reviewed between 1 January 2005 and 31 August 2006, but which were still awaiting approval, would face on-site inspections—no doubt adding to the already very large caseload of pending inspections (see China: 11 September 2007: SFDA Announces New Checks for Recently Reviewed Drugs in China). Not coincidentally, new drug registrations nosedived in the second half of 2007 (see China: 5 October 2007: Rate of New Drug Approvals Slows in China).
Of course, the latest phase of China's struggle to remove dubious registrations is partly due to the far more rigorous practices introduced under the New Provisions for Drug Registration in October 2007. Among other changes, the measures imposed a higher burden of proof on applicants that assert superiority in quality, safety and efficacy for any molecule filed as a "new" drug; previously, this claim had been easy to make. At the same time, the New Provisions introduced a specific category for generics in order to better delineate differences between known molecules and genuinely novel drugs (see China: 19 July 2007: New Drug Registration Rules Set to Encourage Innovation in China). Any firm found to be guilty of infringing these rules can be banned from re-applying for either clinical trials or a manufacturing license for at least one year, with the possibility of further sanctions.
Outlook and Implications
Local observers are confident that the SFDA's drive to rehabilitate drug registrations will not affect large foreign manufacturers, who are in any case subject to different regulations if acting as importers. However, even if multinationals have little to fear from the official purge, regulators are planning four new laws this year that will complement the New Provisions introduced in October. As well as looking at pharmaceutical excipients and traditional medicines, there will be more action on plant inspections for registration submissions, technology transfer projects and minimum quality standards. If the SFDA is to meet all its objectives this year, it appears unlikely that the regulatory system can absorb more reforms at the same time as conducting a full-scale clearout of drug registrations.
Related Articles
- 18 February 2008: More Action Pledged on Drug Quality, Donation Rules in China
- 15 February 2008: China Apprehensive About U.S. FDA Inspections
- 29 January 2007: FDA-Style Fast-Track Mechanism Nears Reality in China
- 4 December 2007: Quality Concerns Lead to Shutdown of 300 Healthcare Companies in China since July