PXL/HO/Cir-134/2017-18                                                                                             Dt: 23.03.2018 

Hyderabad

Dear Sir/Madam,

Subject: Greater Market Access for Indian Pharmaceutical products and medical equipment in the Chinese market

We refer to our circular dt: 12^th April 2017sharing the draft notification inviting comments on the matter concerning the Registration Management of Imported Drugs.

In continuation of the above, we would like to inform member companies Council is in receipt of communication from Embassy of India, Beijing stating that the General Office of the State Council, China has released the guidelines with the aim to encouraging innovation in drugs and medical equipment by reforming the review and approval system in the medical sector.

The new guidelines include the following provisions:

    I.   Authorities in China will now accept data collected from clinical trials conducted outside the mainland for applications to register drugs and medical equipment. However, the data collected from clinical trials conducted at more than one center and must meet Chinese regulations for registration of drugs and medical equipment.

  II.   The review and approval for urgently needed drugs and medical equipment should become faster, including those that can be used to treat severe life-threatening diseases lacking effective treatment or are urgently needed for public health.

III.   Measures will be introduced to promote drug innovation, including setting up of a catalog of marketed drugs, building a system linking the review and approval of drugs with their patents, and improving the protection of drug trial data.

IV.   The clinical use of new types of drugs will be supported. Local medical authorities are asked to include new medicines in the coverage of basic medical insurance and the scope of centralized procurement by public hospitals.

These new provisions are likely to offer faster drug registration and easier market access for Indian pharmaceuticals and medical equipment in China. Members are therefore requested to take advantage of these new provisions for a better and faster market access in China.

With regards,