On July 10, the state administration of pharmaceutical supervision and administration of the People's Republic of China issued the "technical guidelines for the acceptance of data from clinical trials abroad", which recognized the simultaneous development of clinical trials abroad of innovative drugs at home and abroad, as well as the development of generic drugs abroad with complete and evaluable data of bioequivalence.
The evaluation criteria of overseas clinical trial data approved by the state food and drug administration include the authenticity, integrity, accuracy, traceability, efficacy and safety of overseas clinical trial data, and the study of ethnic differences.
For drug registration applications for serious diseases, rare diseases, pediatric diseases and lack of effective treatment methods, if the overseas clinical test data are assessed as "partial acceptance", a conditional acceptance clinical trial data method can be adopted to collect further efficacy and safety data for evaluation after the drug is marketed.
It was two months ago another policy to supplement, May 23, the state food and drug administration, the state WeiJianWei jointly issued the "on optimizing the drug registration review announcement parties on matters relating to the examination and approval, mentioned for overseas listed and there is no effective treatment of disease prevention and treatment of severe life-threatening and rare diseases drugs, the applicant for imported drugs registration by the research that there is no racial difference, you can submit a clinical trial data sources outside directly declare listed drug registration.
The import may be approved directly if the aforesaid application for clinical trials of imported drugs, which has been accepted and submitted for exemption or exemption of clinical trials before this announcement, meets the requirements of the "measures for the registration and administration of drugs" and relevant documents.
The two policies are seen by the industry as a sign of the liberalisation of the 5.2 categories of import registrations, especially for low-priced Indian generics that have not been approved for years.
▍ that means the following categories of drugs may benefit from this policy:
Innovative medicine, Ⅲ period clinical trial including east Asian, especially Chinese research of subgroups.
Imported generic drugs/domestic generic drugs produced generic drugs, the original developed drugs did the above study on east Asian people, especially the Chinese subgroup.
Clinical essential drugs, such as critical diseases, rare diseases, pediatric drugs and drugs without effective treatment methods can be appropriately relaxed, but further efficacy and safety data need to be collected for post-marketing re-evaluation after being marketed.
This means that the products of the original manufacturers that import generic drugs already on the market in China or Japan are likely to benefit from the policy. Introduction of such imported generic drugs has the biggest impact on expired generic drugs, and the import of imported generic drugs may further push the price reduction of expired generic drugs.
▍ import generics: India declared the most
After sorting out the list of products that have declared 5.2 types of imports or imported generic drugs since 2016, it is found that the countries and regions with the highest number of products declared are India, Switzerland, Taiwan and Greece.
The company with the largest number of products declared is Dr. Redy of India, and the products declared include delarosi dispersible tablets, acatron acetate tablets, fluorovirasan injection, sildenafil citrate tablets, rivaroxaban tablets and silam carbonate tablets. Next up is novartis/sundance, whose products include escitalopram oxalate tablets, voriconazole tablets, mumetasone furfurfurate nasal spray, sametroticasone powder inhaler and left ethoxetine tablets.
Many domestic manufacturers have participated in the import projects of 5.2 types of imported drugs. For example, jiangsu xiansheng cooperated with Celon Pharma S.A., China resources jiuxin cooperated with farmer, zhaoko cooperated with BioQ Pharma Limited, HOLOPACK Verpackungstechnik GmbH, guangzhou hanguang cooperated with Pharmanel Commercial Pharmaceutical S.A.