Hello NMPA: New Drug Approvals, Online Database And More
Executive Summary
China grants approvals to Gilead’s HIV combo Biktarvy and Mitsubishi Tanabe Pharma’s Radicava in the latest batch of new product clearances. Meanwhile, a new online database for marketing authorization holders goes live.
The latest approvals of new drugs in China include Gilead Sciences Inc.’s HIV drug Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide). There are an estimated 150,000 newly diagnosed HIV carriers in the country and the figure is increasing, and authorities are prioritizing anti-HIV and other treatments for major infectious diseases for fast-track review and approval.
The product provides a new once a day, one-pill option to adult HIV carriers looking to replace their current therapies. It is the second HIV treatment to be approved this year for Gilead in China, where it obtained a nod for Descovy (emtricitabine and tenofovir alafenamide) last December. Biktarvy gained approvals in the US and EU in 2018.
In other decisions, Japanese drug maker Mitsubishi Tanabe Pharma Corp. has obtained Chinese approval for Radicava (edaravone) for amyotrophic lateral sclerosis (ALS). The drug, included in a list of products for priority reviews in May, was cleared for marketing just three months later, marking record speed.
ALS is one of 121 rare conditions listed in China's first official national list of such disorders, and there are estimated 20,000-30,000 ALS patients in the country.
Edaravone was first approved for ALS in Japan in mid-2015, as Radicut, and is now approved in six countries.
MAH Database Goes Online
In other regulatory moves, the National Medical Products Administration (NMPA) has released a new database for marketing authorization holders (MAH) in China, in its latest move to make information more accessible and shareable among regulators.
The agency noted that as of July, there were 156 MAH holders covering 3,239 products listed in the database.
The public can also access the data via the NMPA’s information sharing portal. In July, the agency also established a English website in a bid to tell its story to the world. (Also see "Hello NMPA: New English Website For China's Regulator, Inspection Scheme Bolstered" - Pink Sheet, 1 Aug, 2019.)
Inspection Activity
The NMPA’s Center for Drug Inspection said that in the first six months of this year, 58 on-site observations or inspections of domestic drug manufacturers by were conducted by 11 overseas regulatory or inspection agencies.
These included the World Health Organization, the US Food and Drug Administration and the UK Medicines and Healthcare products Regulatory Agency, among others.
The inspections involved 54 companies in 15 provinces and cities across China but mainly located in Jiangsu, Zhejiang and Shandong provinces. The activity covered a total of 158 products including 107 ingredients, seven injections, 21 oral solid preparations and 23 other drugs.
The deficiencies found during the inspections included quality control and assurance, documentation management, confirmation and verification, manufacturing management and equipment.