Imported drugs – Accestra Consulting https://www.accestra.com Your long term strategic partner for regulatory compliance. Mon, 06 May 2019 13:59:52 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.5 https://www.accestra.com/wp-content/uploads/2019/03/cropped-accestra2-32x32.png Imported drugs – Accestra Consulting https://www.accestra.com 32 32 How is the Approval Procedure Change Affecting CTA in China? https://www.accestra.com/how-is-the-approval-procedure-change-affecting-cta-in-china/ Mon, 06 May 2019 11:17:48 +0000 http://www.accestra.com/?p=2298 Until May 6th, 2019, the acceptance number announced by China CDE (Center for Drug Evaluation) under China drug clinical trial negative approval system has reached 577. It has been 9 months since the first batch of clinical trial negative approval published by CDE on November 5th, 2018. This new procedure change was designed to significantly improve the drug review timeline and to encourage drug innovation in China. What is the implementation of this negative approval system of CTA then? And what is the impact on drug registration in China?

It can be indicated from the statistical chart below:

  1. The majority of the chemical drug CTA application so far is Class 1 New Drug；
  2. After the negative approval system became effective as well on Imported Drug Class 5.2 (non-brand-name-drugs that have been marketed in other countries, but not yet in China), the number of imported generic drug application has increased. The international pharmaceutical companies such as Novartis are actively introducing their own generic drugs business to China market;
  3. The anti-cancer drug is still a hot spot in domestic clinical research.

Background:

The time China drug clinical trial approval (CTA) system was changed from a positive system to a negative system is July 27th, 2018, when the Announcement on Adjusting the Approval Procedure for Drug Clinical Trial Review was published by former China CFDA. It proposes a mechanism for an applicant to discuss with CDE before submitting the CTA application. If the applicant does not receive any negative comment within 60 working days after the CDE accepts the CTA application, the applicant can proceed with the clinical trial directly based on the protocol submitted without positive approval. The new application procedure for NDA is as follows:

The new application procedure for NDA is as follows:

]]> China Imported drugs application statistics in 2019 Q1 https://www.accestra.com/china-imported-drugs-application-statistics-in-2019-q1/ Tue, 30 Apr 2019 04:23:33 +0000 http://www.accestra.com/?p=2288 From the second half of 2018, China CDE (Center for Drug Evaluation) has significantly speeded up its review and approval process of imported drug, which can be considered as the result of the national faster imported drug approval policy. According to the statistics of the first quarter of 2019, the number of acceptances and the number of approvals for imported drug applications continued to grow on the basis of the fourth quarter of 2018.

Acceptance of imported drug applications:

In the first quarter of 2019, China CDE accepted a total of 222 applications for imported drugs. Among them, the number of applications for therapeutic biological products was the highest, reaching 73 acceptance; the second was the new drug of Class 1, with 47 acceptance; The Class 5.1 and Class 5.2 drugs were basically the same, with 37 and 42 acceptance respectively; Class 2.4 drugs were the least, with only 19 acceptance.

Among the 222 imported drug acceptance, 138 of them are clinical applications, and the other 80 are marketing applications. And in all the drug varieties for marketing application, 6 of them are put in the priority review track of CDE: Nivolumab injection (Bristol-Myers Squibb), Adalimumab injection (AbbVie), Patezumab injection (Roche), Dabrafenib capsule (Novartis), Trametinib tablets (Novartis) and Pralatrexate injection (Mundipharma).

Imported drug clinical trial application approval:

In the first quarter of 2019, there are total 55 imported drug clinical trial applications approved by China CDE, including 15 of Class 1 new drugs, 12 of Class 5.1 drugs, 6 of Class 5.2 drugs, 4 of Class 2.4 drugs and 6 of biological products.

Marketing approval of imported drugs:

In the first quarter of 2019, the total marketing approval number of imported drugs is 18, including 10 drug varieties. And three of them were approved with priority review process as urgently needed drugs: Evolocumab Injection (Amgen), Spinraza injection (Biogen) and Dulaglutide Injection (Eli Lily). For these three drugs it costs 6-8 months in average from CDE accepting the application to the market approval being issued by NMPA.

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