Chinese FDA publishes draft regulation that may significantly accelerate registration process for foreign medicines in China

The Chinese Food and Drug Administration (CFDA) recently published a draft regulation intended to speed up the registration of new imported medicinal products.  The draft document, dated 17 March, was released shortly after the head of the CFDA expressed his intention to welcome more foreign medicinal products into China during China’s annual plenary Two Sessions meetings.

Under the draft regulation, it will no longer be required to apply for a local clinical trial authorisation when an applicant relies on an existing multi-regional clinical trial (MRCT).  In addition, a Chinese registration will no longer depend on a successful home country registration.  Currently, Chinese regulations – which are considered very burdensome by foreign pharmaceutical companies – require an authorisation to conduct local trials in addition to an MRCT application, and a New Drug Application (NDA) to obtain approval of new imported medicinal products.  The new rule is retroactive, and hence will be applicable to currently pending marketing authorisation applications.

The proposed changes, when implemented, are likely to significantly shorten the lengthy approval process for foreign new medicinal products (potentially with up to two years), and are a great step forward towards tackling China’s current lag in approvals of medicinal products.  This development is likely to renew the interest of multinational pharmaceutical companies in launching their innovative products in China.  Comments on the draft regulation should be submitted by 20 April via www.chinalaw.gov.cn.  We provide an English transation of the draft regulation below:

The State Food and Drug Administration Decision regarding Adjustments to matters relating to the Administration of Drug Registration

(Draft for Public Comment)

Per the requirements of the State Council Opinion regarding Reforming the Review and Approval Procedures for Drugs and Medical Devices (Guo Fa (2015) No. 44), to encourage the approved simultaneous clinical trials, both in China and abroad, of new drugs not yet marketed outside China, to reduce the time lag between foreign and domestic marketing, and to satisfy the public’s clinical need for new drugs, the State Food and Drug Administration has decided, after deliberation at its executive meeting, to make the following adjustments to matters relating to the administration of imported drug registration:

1. Except for vaccines, the requirement shall be waived that the clinical-trial drugs undergoing international multi-centre clinical drug trials in China must have been approved outside China or must have entered phase-II or phase-III clinical trials.
2. Drugs that have completed an international multi-centre clinical trial that is [in part] conducted in China shall be immediately eligible to apply for drug marketing approval; such applications for marketing approval shall comply with the requirements provided in the Measures for the Administration of Drug Registration and other relevant documents.
3. For new chemical drugs and innovative therapeutic biologic drugs for which import applications are pending, the requirement shall be waived that they must have been approved for marketing in the country or region where their foreign drug manufacturer is domiciled.
4. Import approval may be granted to those applications for approval filed prior to the promulgation of this Decision upon a motion for an exemption from imported clinical drug trial on the basis of international multi-centre clinical trial data, if such motion meets the requirements.

This decision shall come into effect as of the [] day of the [] month of []. Should there be any conflict between provisions in the relevant drug administration regulations on the administration of imported drug registration and this decision, this decision shall prevail.