In the eyes of most of the Chinese people engaging in the pharmaceutical industry, imported pharmaceutical products have been an area where the Chinese official regulation is weak, for which there are objective reasons: such as, inadequate number and quality of CFDA inspector teams; large expenses and long duration for going abroad to inspect; inspection on foreign pharmaceutical enterprises involving communication with relevant institutions among different countries. However, the above explanations cannot long serve as the shield for Chinese official to weaken regulation on imported pharmaceutical products as calls from Chinese pharmaceutical enterprises and patients for medication safety are growing.
With the increasing intensity of reform of the new Administration, CFDA has continued to increase the regulation on the quality of Chinese and foreign pharmaceutical products according to requirements of relevant documents of the State Council, wherein, the regulation efforts on imported pharmaceutical products have been increased since the beginning of 2015, which eventually shows the progressing trend of pharmaceutical product regulation work to Chinese consumers.
The followings are my introduction to the new changes in the regulation of imported pharmaceutical products by the Chinese official over the past year according to CFDA official documents and relevant reports and by summarizing and analyzing relevant information.
Step 1: Continuing to increase inspection on foreign pharmaceutical enterprises
CFDA continued to increase the on-site inspection efforts on imported pharmaceutical products in 2015. Information of the following table is from documents released by CFDA in 2015, which summarizes situation of foreign pharmaceutical enterprises that have been warned.
To see the list of overseas pharmaceutical companies to receive the warning, please click here: LIST OF COMPANIES
Step 2: Checking of imported pharmaceutical products in the clinical trial checking
CFDA chose 1622 registration numbers on July 22, 2015 requiring them to conduct clinical trial data self-inspection and spot check. As the work progressed, many varieties of many enterprises were found to exist with serious falsification problem, thus were refused the approval; while most of other enterprises chose to actively withdraw the varieties. The following table summarizes the brief information of imported pharmaceutical products in the clinical trial checking list.
Step 3: New requirements on registration inspection for imported pharmaceutical products
The Announcement of China Food and Drug Administration on Matters Relating to Pharmaceutical Product Registration Inspection (No.36, 2016) released by CFDA on February 5, 2016 requires cleaning the imported varieties having long been unable to be completed registration inspection due to many reasons. The specific requirements are as follows:
Total number of imported varieties involved in the clinical checking: 171
Number of varieties involved by Japanese enterprises: 17
Number of varieties involved by Indian enterprises: 15
Number of varieties involved by South Korean enterprises: 7
Number of varieties involved by European and American enterprises: 132
3.1 Pharmaceutical product registration applicants shall submit data, sample and relevant reference standard used for pharmaceutical product registration inspection to relevant pharmaceutical product inspection agency within 6 months after the day receiving the Inspection Notice issued by the acceptance department.
3.2 If the pharmaceutical product registration applicants are required to supplement data, sample and relevant reference standard during the pharmaceutical product registration inspection, the applicants shall submit the supplementary data, sample and relevant reference standard to relevant pharmaceutical product inspection agency within 4 months after the day receiving the Supplementary Data Notice issued by the pharmaceutical product inspection agency. The time for the supplementary data, sample and relevant reference standard will not be included in the registration inspection time limit.
3.3 Failure to submit data, sample and relevant reference standard within the specified time after acceptance of registration application, or failure to supplement data, sample and relevant reference standard within the specified time during registration inspection will be deemed as circumstance of failure to supplement data within the specified time limit during the pharmaceutical product technical evaluation, and the pharmaceutical product evaluation agency will not grant approval according to the circumstance explanations issued by relevant pharmaceutical product inspection agency.
3.4 For the pharmaceutical product registration applications that have been accepted before release of this announcement, if the data, sample and relevant reference standard are not submitted within the above time limit, relevant data, sample and relevant reference standard shall be made up within 30 days from the day of release of this announcement, and those not submitting within such the time limit will not be granted approval.
The table in this announcement involves 543 pharmaceutical product registration varieties in total, covering the imported products of Indian, South Korean and European and American pharmaceutical enterprises, etc. This announcement shows CFDA’s commitment and energy to solve the history backlog.
Step 4: Implementation of Chinese Pharmacopoeia also starting to cover imported pharmaceutical products
CFDA released another document on February 19, 2016: Notice of CFDA on Matters Requiring Imported Pharmaceutical Products to Meet the Pharmacopoeia of the People's Republic of China (SYJYHG  No.18), requiring all pharmaceutical products imported to China to meet the specific variety requirements or general technical requirements of Chinese Pharmacopoeia. The document clearly mentions: All imported pharmaceutical products must meet relevant requirements of the Pharmacopoeia of the People's Republic of China, which shall be inspected by ports for imported pharmaceutical products according to relevant requirements of 2015 edition of Pharmacopoeia of the People's Republic of China, and those not conforming are not allowed to be imported.
Step 5: Strengthening checking in clinical trial aspect
CFDA released Announcement of CFDA on Not Granting Registration to the Hepatitis B Core-related Antigen (HBcrAg) Assay Kit of Fujirebio Inc. (No.44, 2016) on February 27, 2016 to not grant such registration due to the irregularities of Fujirebio Inc. in the clinical trial of Hepatitis B core-related antigen (HBcrAg) assay kit and not accept the registration application within one year after the day of not granting such registration, as stipulated by Article 78 of the Administrative License Law of the People's Republic of China.
This document signals that: CFDA has carried out the clinical trial checking of medical devices and diagnostic reagents, and increased efforts in inspecting imported products.
We can foresee the followings according to the above summarizing and analysis of relevant regulations and pharmaceutical industry information from 2015 to the present:
Firstly, CFDA will continue to increase supervision and inspection on foreign pharmaceutical enterprises, including not only the ex post supervision and inspection but also the gradual increase of the on-site checking, etc. involved in R&D.
Secondly, CFDA will gradually withdraw the super-national preferential treatment of foreign enterprises, and require them to accept the same regulatory requirements as Chinese pharmaceutical enterprises, for example, enterprises entering China must meet the technical requirements of the latest edition of Chinese Pharmacopoeia.
Thirdly, CFDA will increase efforts in clinical trial regulation of imported pharmaceutical products. Both the July 22 Event in 2015 and announcements in February 2016 show that such work is being constantly conducted.
Fourthly, we can foresee that with the carrying out of the above work, foreign small enterprises will gradually lose their market in China, but European and American large enterprises will gradually adapt to the regulatory pressure and continue to expand the business scope by depending on the advantages accumulated in their years of conduct of business in the Chinese market.
Published: March 21, 2016