Draft Regulations Concerning the Inspection of Foreign Drug Manufacturing Enterprises

05 September 2012

Grace Chen

On 20 August 2012, the State Food and Drug Administration (SFDA) published a draft of the Foreign Drug Manufacturing Enterprises Inspection Administrative Measures (the Measures) on its web site for public comment on or before October 8, 2012. An English translation of the SFDA notice and the draft Measures, along with a summary of the background information is attached for your reference.

Background

Drug safety has long been a matter of great concern to all drug regulatory authorities, and on-site inspections of drug manufacturing sites have long been an established part of the drug approval process. In fact, international practice calls for the regulatory authority of a country to conduct Good Manufacturing Practices (GMP) inspections of sites where drugs imported to that country will be manufactured.

Under Chinese law, imported drugs must be manufactured in a facility that is compliant with the GMP of its own country/region of manufacture as well as China’s GMP. It is also stipulated that China’s drug regulatory body, SFDA has the right, as part of the approval process for the importation of a drug into China, to conduct on-site inspections with respect to the R&D and manufacturing activities of foreign drug manufacturing enterprises.

However, notwithstanding the existence of regulations addressing this issue, SFDA’s implementation of rules for monitoring and supervising the sale and use of imported drugs has always lagged behind the corresponding regime for domestic drugs for various reasons. This includes the fact that China’s GMP had not yet reached the necessary thresholds to merit international recognition, as well as the obstacles posed by language and distance.

Preparatory Groundwork

Over the years, SFDA has conducted a significant amount of preparatory work to equip itself with the tools necessary to inspect foreign drug manufacturing sites. In the 2007/2008 time frame, SFDA began organising classes to train selected SFDA personnel on GMP inspection techniques, inviting seasoned experts from United States and Europe to educate these individuals on the newest concepts relating to US GMP, EU-GMP and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), in order to help them understand drug R&D, manufacturing management and the laws and regulations relating thereto. These SFDA personnel are also provided with information concerning the job responsibilities of the various departments in a drug manufacturing enterprise, ranging from drug manufacturing to quality management and quality control so that they would be able to grasp the specific applications of GMP in the entire drug manufacturing process. The 2010 amendment of China’s GMP to bring it in line with the GMP requirements set by the World Health Organisation may have been an important catalyst for China to commence inspections of foreign drug manufacturing sites. This was followed by the promulgation of the Drug Manufacturing Quality Management Standards Certification Administrative Measures by SFDA on 2 August 2011.

SFDA Personnel Dispatched to Conduct Foreign Inspections for the First Time

In 2011, SFDA began dispatching its personnel to conduct inspections of foreign drug manufacturing sites. For the first time, thirty-three GMP inspectors designated by SFDA conducted on-site inspections of seven foreign enterprises, namely, Eli Lilly, Novartis, Roche, Sanofi, Mitsubishi Taneda, Dr. Reddy's and Daewoong, at their manufacturing sites in the United States, Japan, Korea, India and Czech Republic to determine whether the drugs manufactured at these sites for import to China complied with GMP requirements. The focus of these inspections is to determine whether these foreign drug manufacturing sites comply with China's newly amended GMP requirements and whether the manufacturing techniques for the drugs imported to China are consistent with the manufacturing techniques reported in the original application submitted to SFDA.

Issuance of Draft Measures for Public Comment

On 20 August 2012, SFDA published the draft Measures on its web site to solicit public comments. These draft Measures set out the process by which SFDA will determine which foreign drug manufacturing sites will undergo inspections, as well as the scope of the inspections, and looks at whether the drug registration submission materials and site materials are consistent with the actual manufacturing process, and if the drug manufacturing process conforms to China’s newly amended GMP. The draft Measures also provide the procedural details relating to (1) setting up and conducting the inspections by SFDA; (2) the submission of information and/or requests by the enterprises via their agents; (3) provision of verbal feedback and written reports, and the requirements that may be imposed by SFDA on the foreign drug manufacturing enterprises in the event that rectification is necessary.

Conclusion and Recommendations

The issuance and solicitation of the draft Measures for public comments indicate that SFDA intends to follow the lead of its Western counterparts by providing guidelines with respect to the inspections of foreign manufacturing facilities and increasing the number of inspections it conducts as part of SFDA approval process for imported drugs, even though these guidelines are not detailed as those provided by the corresponding regulatory authorities in the United States or the European Union.

We would advise pharmaceutical companies that are importing or intending to import their products into China to review these draft Measures carefully and consider taking this opportunity to provide comments and suggest changes to SFDA.

To read the SFDA notice and the draft Measures, please click here.

If you have any questions or wish to seek assistance with preparation of comments or suggestions for submission, please do not hesitate to contact:






 

Grace Chen

Grace Chen
Partner
Tel: + 86 10 5933 5688
Fax: + 86 10 5933 5666
Email: grace.chen@twobirds.com