China introduces revised approval process for drugs and medical devices

Out-Law Analysis | 07 Dec 2015 | 2:46 pm | 3 min. read

FOCUS:  New procedures for drug registration and approval in China should open up opportunities for companies to explore concurrent drug development opportunities for innovative drugs both in and outside China.

The China Food and Drug Administration (CFDA) recently announced new procedures for drug registration and approval, to speed up the regulatory review and approval system for pharmaceutical products and remove the current backlog of applications for drug registration in China. In its 'Announcement on Several Policies on the Appraisal and Approval of Drug Registration', the CFDA laid out plans to improve the quality and efficiency of the appraisal and approval process with the introduction of an expanded fast track procedure.

The reforms are designed to streamline the regulatory review and approval system for specific types of drug registration. However, it will also impose more severe punishment on any parties involved in the "fabrication of clinical data", the CFDA said.

From 1 December, the fast track approval process has been expanded to include a broader category of drugs including: innovative drugs approved abroad but which are to be manufactured locally in China; drugs manufactured at a US and EU approved facility and under-going a review by the FDA and the EMA for a concurrent marketing drugs to treat diseases prevalent in China; drugs needed urgently for clinic trials that feature advanced technology, innovative treatment methods and obvious therapeutic advantages; drugs to treat HIV, malaria, malignant tumours, severe infectious diseases and rare diseases; drugs listed in the national key special scientific and technology projects and national key research and development plans; and finally, paediatric drugs and drugs designed for the elderly. The broader fast track procedure has parallels with mechanisms for accelerated approval in other jurisdictions such as priority review in the US, accelerated assessment in the EU and Sakigake in Japan.

The announcement follows an agreement announced by the Chinese and US governments in January this year on a streamlining of China's regulatory process to reduce barriers to trade for US medical devices and drugs, and the publication of an 'opinion' in August by China's state council on how to reform the country's review and approval process for drugs and medical devices.

In the January announcement, China agreed to push forward the reform of its review and approval system to remove the backlog within two to three years. Products tested using multi-regional clinical data including data from China would receive waivers to avoid the need for duplicate testing in China, and China would take marketing approval of a product in another country into account as part of its licensing process, it said.

The state council opinion in August set out a series of measures to improve the regime, including a new classification system for products. The term 'new drugs' under the classification system now refers to drugs that have not been sold anywhere in the world, and has been split into two sub-classifications: 'innovative' new drugs, and 'improved forms' of drugs.

A pilot 'market authorisation holder' programme will also be launched, the council said. This allows private research institutions and companies to apply for authorisation, and to pass the marketing rights to a manufacturer once the research has been done. Currently only drug manufacturers can gain this approval.

Synchronous in-country trials will be allowed for new drugs that have not yet been marketed overseas, and clinical data collected from multicentre trials can be put forward as part of an application, the council said.

Other improvements promised by the CFDA include changing the classification of novel and generic drugs, improved appraisal and approval of clinical trial applications, and the centralised appraisal of drugs that fall into the same category, while the administration will continue to strictly examine the safety and effectiveness of drugs, it said. Under the new classification system there are plans to classify pharmaceutical products that have been marketed outside China but not in China as generics so they will qualify for approval under an abridged procedure. 

The expansion of the abridged approval process to medicines already marketed outside China appears similar to schemes already in operation in Singapore and New Zealand. The process has the potential to save costs and avoid duplication of resources across countries and allow China to focus its resources on those innovative medicines that have the most value to the Chinese health system.

Beijing-based Ai Ping Bao is a commercial law expert at Pinsent Masons, the law firm behind