China Lifesciences Monthly Update – December 2017

CFDA clarifies the prioritised evaluation regime, 28 December

China Food and Drug Administration ("CFDA”) issued the Opinions on Encouraging the Prioritised Evaluation and Approval for Drug Innovations (“Opinions”) on 28 December 2017. The Opinions set out the type of drugs that may enjoy the prioritised evaluation regime, which includes certain drugs of significant clinical value or great clinical advantage in the treatment of certain diseases. The Opinions also provide the proceedings and requirements of the prioritised evaluation.

CFDA issues regulation for online medical devices distribution, 20 December

CFDA issued the Measures for the Administration and Supervision of Online Sales of Medical Devices ("Measures") on 20 December 2017. They will take effect on 1 March 2018. The Measures regulate the online medical device distributors and relevant third party services platforms. It clarified the qualification requirements and recording obligations for the distributor and platforms. It also requires the platforms to establish a system to register, verify and monitor the distributors that run a business on the platform.

CFDA and NHFPC seek comments on the regulation of pharmaceutical representatives, 19 December

CFDA and the National Health and Family Planning Commission ("NHFPC") announced the Administrative Measures for the Registration and Record-filing of Pharmaceutical Representatives (for Trial Implementation) (Draft for Comment) ("Draft") on 19 December 2017. It is open for public consultation until 19 January 2018. The draft provides the definition, responsibility, qualification and registration requirements of pharmaceutical representatives. Market Authorisation Holder shall record their employed representatives on the designated platform and seek approval from the medical institutions before conducting any academic promotion activities.

CFDA seeks comments for compassionate use of drugs in clinical trials, 15 December

CFDA published the draft Administrative Measures for Drugs Compassionately used in Extended Clinical Trials (Draft for Comment) (“Draft”) on 15 December 2017. It is open for public opinion until 15 January 2018. The Draft provides that under certain conditions, unapproved drugs may be released for patients with urgent clinical need. The usage shall be free of charge and must be approved by the authority in advance. The data collected during the usage may be used to assess the safety evaluation component of the drug registration process.

CFDA speeds up the approval of urgently needed drugs, 13 December

CFDA issued the Technical Guide to Conditional Approvals of Launching Drugs Urgently Needed in Clinical Trials onto the Market (Draft for Comment) (“Draft”) on 13 December 2017. The Draft is open for public comments until 14 January 2018. The draft provides that the CFDA may approve the market authorisation for certain drugs before the clinical trial is completed. This is available to drugs used to treat serious or rare diseases with sufficient data to predict the clinical value, or drug used to treat rare disease that have been approved abroad. For the applicable drugs, clinical trials can be conducted after it received market approval.