In 2017, the CFDA approved the import of new drugs for panoramic observation

Based on the published data of CFDA/CDE, this article has incorporated new drugs and biological drugs (BLA).

After searching by CFDA and CDE official website, the author has determined the following 40 imported varieties (see the table below). In 2017, CFDA was granted a new approval for listing. Among them, 6 biological products or vaccines, and the rest are small molecule drugs or compound drugs.

Novartis, six varieties approved;

Johnson & Johnson, 6 varieties were approved;

Boehringer Ingelheim, 5 varieties approved.

anti- Cancer Or prevention, 9 paragraphs, including solid tumors and hematologic neoplasms;

Type 2 diabetes, 6;

Hepatitis C, 6 paragraphs;

Central Nervous System disease , 4 models;

Autoimmune diseases, 4;

anti- hypertension Or pulmonary hypertension, 3 and so on.

Released in 2016 by the General Administration of Administration of the CFDA drug The speed of listing of new drugs and generic drugs was significantly accelerated after the registration application backlog implemented the opinion of prior review approval. At present, CDE has issued 25 batches of 423 varieties into the priority review process (the previous batch of 26 was not found). Many of the 40 varieties are prioritized for review.

Through the priority review of these drugs, the time-to-market and foreign time differentials for imported innovative drugs in China have been reduced to 1 year and 5 months (Austenitin, AZD9291), followed by Novartis's Shakuba Quattan Sodium Than The time to market in the United States is 2 years and 1 month later.

In addition, the Food and Drug Administration increased the number of reviewers. At present, CDE has increased from the original 150 to more than 800.

The next part will review some of the 40 heavy drugs, especially the Chinese market demand.