Stricter administration of the whole lifecycle of drugs and medical device

The China Food and Drug Administration (the “CFDA”) issued the Relevant Policies on Encouraging Innovation and Implementing the Life-Long Management of Drugs and Medical Devices (Circular No.54, 2017) (the “Draft”) on 11 May 2017. The Draft clarifies the liability of Market Authorisation Holders (“MAH”), Contract Research Organisations and other relevant parties as well as addressing other specific issues in the lifecycle of drugs and medical devices.

The key ideas addressed by the Draft are summarised below:

1. Outlining the legal responsibility of MAHs MAHs will have all legal responsibility for preclinical research, clinical trials, manufacturing, and quality of raw material, distribution, clinical use guidance and reporting of adverse drug reactions (“ADR”). Research companies, researchers, manufacturers and distributors who are entrusted by an MAH to conduct corresponding activities will have legal responsibility for the marketed drug in accordance with the law, regulations and corresponding agreements.
2. Improve the ADR and incident reporting system of drugs and medical devices MAHs shall report all ADRs of their products, improve quality control measures and propose the amendment of the specification and labelling of the products accordingly. If an MAH conceals or delays the report and the medical institution or the patients report the ADR instead of the MAH, the MAH will be severely punished by the regulatory authorities.
3. Reevaluation of marketed injections The Draft encourages that the safety, effectiveness and quality control of approved injections should be reassessed.
4. Improve the medical device reevaluation system If changes are found in the safety or effectiveness of marketed medical devices, the relevant MAH shall conduct self-reevaluation and then improve the product in a timely manner. Similar requirements apply if problems and quality defects are found in the event of an ADR.
5. Serious investigation and punishment of clinical trial data fraud Both parties to the clinical trial agreement as well as specific researchers will have full responsibility for the reliability of clinical trial data.
6. Regulate academic promotion behaviour Medical representatives are responsible for the academic promotion of new drugs, introduction of new drug knowledge to clinicians and listening to the feedback of clinical use of new drugs. Medical representatives are prohibited from having sales responsibilities or contacting doctors in private. Medical authorities’ employees must not provide information regarding the number of medical prescriptions issued by any doctor to medical representatives or any personnel from drug manufacturers. Any academic promotional activities carried out by medical representatives in medical institutions should be open to the public and should also be recorded with the designated departments of medical institutions. MAHs and pharmaceutical manufacturers should record the list of medical representatives on the website designated by the food and drug regulatory authorities and make the list available to the public. If medical business is carried out in the name of a medical representative that is not on the record, the relevant companies and medical representatives will subject to investigation and punished by the relevant department.
7. Electronic technologies should be used more frequently in the review and approval process to enhance the capacity of evaluation.
8. In the evaluation process, MAHs shall ensure the consistency of the quality and effectiveness of the samples submitted for registration and the samples used for clinical trials.
9. The CFDA is responsible for the administration of the research and development process as well as the implementation of the ‘Good Laboratory Practice’ and the ‘Good Clinical Practice’. The relevant provincial FDA will be responsible for the administration of the manufacturing process and the implementation of the ‘Good Manufacturing Practice’. City level FDA will be responsible for the administration of the distribution process and the implementation of the ‘Good Supply Practice’.
10. To establish a more professional inspection team.
11. Strengthen international cooperation. The CFDA will actively participate in the enactment and revision of international rules and standards to gradually realise the international sharing and mutual recognition of the standards and results of evaluation, inspection and trial.

The Draft summarised the major administrative measures that could be adopted by the CDFA in relation to the lifecycle of drugs and medical devices. The Draft also clarifies the competent authorities and liable parties responsible for dealing with illegal behaviour. Pharmaceutical companies should be well prepared for such new administrative measures to ensure their compliance if the above provisions become effective. Special attention shall be given to the aforementioned recording rule in relation to medical representatives.