SFDA’s 2009 Work Plans for the Administration of Pharmaceuticals and Medical Devices
During the National Food and Drug Administration Working Conference held recently, the State Food and Drug Administration (SFDA) laid out plans for key work regarding the supervision and administration of drugs and medical devices in 2009. This China Update: Pharmaceuticals & Medical Devices Special will summarize SFDA’s work relating to the administration of drugs and medical devices in 2008, then brief you on the highlights of its work plans for 2009, and finally analyze newly issued regulations and possible regulatory changes related to drugs and medical devices in 2009.
SFDA’s Drug Administration Work in 2008
SFDA's reputation has been severely tarnished by the corruption charges brought against its former head Zheng Xiaoyu since 2007. During Zheng’s tenure, some of the new drugs that were approved for manufacture were existing drugs in different dosage forms or drugs with new branding. To overhaul the administration of drugs, SFDA launched a broader rectification campaign. More specifically, with the implementation of the Measures for the Administration of Drug Registration on October 1, 2007, SFDA has tightened the drug registration review process. This shift in policy has resulted in in-depth reviews of drug application documents submitted to SFDA after October 1, 2007, to verify all the information provided in the applications through pharmacological, toxicological, and clinical trial analyses.
In 2008, SFDA conducted a concentrated review of drug applications submitted prior to October 1, 2007. SFDA has reviewed a total of 25,000 drug applications, of which it approved 9,200 applications, or 37 percent of the total. SFDA has completed its review of 177,000 priorapproved drug applications, and has deregistered some counterfeit drugs.
In addition, SFDA received 3,413 drug applications in 2008, a decrease of 18 percent and 75 percent in comparison with 2007 and 2006 respectively. At SFDA’s press conference in February 2009, Wei Zhang, director of the drug registration department, said that “the main reason for this decrease is due to the rapid reduction in the number of generic drug applications. Compared to 2007 and 2006, the number of generic drug applications has decreased by 46 percent and 85 percent respectively.”
Highlights of SFDA’s Work Plans for the Administration of Drugs in 2009
First, SFDA plans to strictly implement the revised Measures for the Administration of Drug Registration in 2009, in order to further standardize the drug approval procedures. Specifically, during the drug application process, SFDA will strengthen on-site inspection for non-clinical studies and clinical trials, as well as production inspection prior to issuing approval for manufacturing, so as to verify the authenticity, accuracy and completeness of the submitted application documents. SFDA will begin to conduct a stricter on-site checks according to the Provisions for the Administration of On-Site Checks of Drug Administration, which was promulgated by SFDA on May 23, 2008, to further facilitate the implementation of the Measures for the Administration of Drug Registration. Moreover, SFDA will continue to encourage and support research on the development of new drugs in 2009.
Second, SFDA intends to revise and promulgate certain drug standards in 2009. From 2008, SFDA has been carrying out an “Action Plan for the Improvement of Drug Standards.” According to this plan, the SFDA revised 1,000 drug standards in 2008. From 2009 onwards, SFDA hopes to revise and promulgate 2,000 drug standards every year.
Third, SFDA has announced that more stringent GMP inspection standards will cover drugs in 2009. confirm From 2009, SFDA will strengthen the on-site inspection, quality control and risk management of drug production. In addition, SFDA claims that it will gradually implement GMP on-site inspection on imported drug manufacturers.
Finally, SFDA will make more efforts to monitor adverse reactions of drugs in 2009. SFDA requests medical institutions to report adverse reactions to drugs more promptly, and encourages drug manufacturers and their distributors to also actively collect and report adverse reactions to drugs.
Newly Issued Regulations and Possible Regulatory Changes Related to Drugs in 2009
On January 7, 2009, SFDA issued the Provisions on Special Approval for the Registration of New Drugs (Special Approval Provisions). The Special Approval Provisions further clarify the conditions, procedures and requirements for obtaining special approval for the registration of new drugs under the general principles of "early intervention, priority review, multi-channel communication and dynamic data supplement." The Special Approval Provisions provide that SFDA will give special approval for the following new drugs:
- Active ingredients that are extracted from plants, animals, minerals or other substances and drug preparations containing such active ingredients, as well as newly discovered ingredients and drug preparations containing those ingredients, that have not been sold in China;
- Chemical raw materials and their preparations, as well as biological products, that have not obtained the approval to be sold in China or abroad;
- New drugs that have obvious clinical advantages in treating AIDS, cancer, or rare diseases; and
- New drugs that treat diseases for which there’s no other effective treatment available.
Additionally, the special approval process is specified as an independent channel separate from other applications for the registration of drugs. SFDA will give priority to the registration of new drugs that are eligible for special approval. Also, SFDA has established a communication mechanism through which it can discuss with applicants relevant technical issues before or during applications for the registration of new drugs. Under the Special Approval Provisions, applicants have more flexibility in the supplementary materials they need to submit in support of their applications for the registration of new drugs.
In order to upgrade the supervision of the entire drug sector, an array of regulatory and legal changes relating to drugs is likely to be launched in 2009. SFDA plans to draw up the Measures of the Administration of Drug Standards, which will provide clearer procedures regarding the formulation, revision, promulgation and implementation of drug standards. SFDA also intends to revise the Provisions for the Administration of the Operation Qualities of Drugs in 2009.
Medical Devices Update
SFDA’s Medical Devices Administration Work in 2008
In 2008, SFDA issued 164 medical device standards. So far, there are 169 national standards and 585 industry standards for medical devices in China. In addition, SFDA, for the first time, imposed joint liability on the Chinese agents of foreign device manufacturers in terms of adverse event reporting, product recalls and after-sales services. Under the Interim Provisions for Further Strengthening and Standardizing the Registration of Medical Devices issued by SFDA on July 23, 2008, SFDA requires a foreign medical device manufacturer that does not have an office in China to appoint a legal entity to act as its agent. The agent needs to act as a liaison between the drug administration authorities and the foreign manufacturer, and is responsible for reporting adverse incidents and recalling medical devices with potential safety problems.
Highlights of SFDA’s Work Plans for the Administration of Medical Devices in 2009
Firstly, SFDA will establish a State Medical Devices Standardization Committee in 2009 to uniformly administrate the existing 22 committees dealing with the standardization and technology of medical devices. Also, SFDA plans to revise more basic and general medical device standards.
Secondly, SFDA will improve the medical device testing system. According to the plan, there are currently 48 medical device testing institutions in China. Specifically, there are 10 medical device testing institutions, including the Medical Devices Testing Center of the National Institute for the Control of Pharmaceutical and Biological Products and the Beijing Institute of Medical Device Testing, that are mainly responsible for the medical device testing and standardization requested by SFDA. In 2009, SFDA plans to rebuild and expand the laboratories of nine national device testing institutions and update their testing equipment.
Thirdly, SFDA will strengthen the establishment of the technical review system. In order to standardize review and approval processes for the registration of class I and II medical devices, SFDA will issue six to 10 guidelines to standardize the technical review of medical device registration procedures.
Fourthly, SFDA will strengthen the administration of medical device safety in 2009, including by supplementing the Classification of Medical Devices Index, drawing up the Rules for Denominating Medical Devices, strictly implementing the Measures for the Administration of the Supervision and Re-evaluation of Adverse Events of Medical Devices, and drafting relevant supplementary documents.
Newly Issued Regulations and Possible Regulatory Changes Related to Medical Devices in 2009
SFDA and the Ministry of Health (MOH) jointly issued the Measures for the Administration of the Supervision and Re-evaluation of Adverse Events of Medical Devices (For Trial Implementation) (Measures), which were implemented on December 29, 2008. The Measures expressly set out the responsibilities and obligations of manufacturers and their distributors in reporting adverse events of medical devices. SFDA requires manufacturers and their distributors to establish a monitoring and management system for adverse events of medical devices, and appoint an agency with full-time (or part-time) staff to undertake the monitoring work of adverse events of concerned medical devices. Also, manufacturers and their distributors are required to keep monitoring records of adverse events of medical devices for no less than five years. Furthermore, the Measures state that manufacturers must provide starting conditions, evaluation procedures and methods for the re-evaluation of medical devices. The Measures also require manufacturers who are aware of potential safety problems related to their medical devices to conduct a re-evaluation. The scope of the evaluation should cover the safety risk analysis report, the technical product report, applicable product standards and instructions, the clinical trial report, labels, instruction books, and other technical data and contents in the registration materials.
In addition, SFDA will accelerate the revising of the Provisions on the Supervision and Administration of Medical Devices in 2009. The amendment is to focus on enhancing the requirements regarding the medical devices’ safety and effectiveness. According to SFDA’s website, there are new chapters to regulate the registration, import and export, and advertisement of medical devices in the amendment.
SFDA will also accelerate the drafting of the Measures for Medical Device Recall in 2009. According to the draft, medical devices that have the following potential safety problems should be recalled:
- If they have caused injury to a person’s health due to design or manufacturing defects;
- If they have not caused injury, but will cause injury under specific situations according to testing and demonstrations;
- If they have violated medical device laws and regulations; or
- If they may cause injury to a person’s health. Furthermore, manufacturers of imported medical devices need to inform SFDA when recalling medical devices outside of China.
If foreign manufacturers need to recall medical devices within China, their agents in China should recall the products. If the manufacturers fail to carry out initial voluntary recalls, relevant administration authorities could request the manufacturers to recall the medical devices with potential safety problems.
In 2009, SFDA plans to draw up the Provisions for the Administration of Qualities of Clinical Trial. Notably, the new provisions will definitely impose more stringent requirements on clinical trials of medical devices. Furthermore, SFDA is likely to introduce the new Provisions for the Administration of Manufacturing Qualities of Medical Devices to regulate all processes of design and development, manufacturing and sale of medical devices in China in the future. For