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RSS FeedPosted by Michael Wonder on 24 Jan 2022
Merck provides US and Japan regulatory update for gefapixant
24 January 2022 - Merck today announced that the US FDA has issued a complete response letter regarding Merck’s new drug ...
Posted by Michael Wonder on 07 Jun 2020
Bayer submits vericiguat for marketing authorization in the EU and Japan for the treatment of chronic heart failure
5 June 2020 - Regulatory submissions based on positive data from Phase III VICTORIA study recently published in the New England ...
Posted by Michael Wonder on 18 Jul 2018
EU and Japan reinforce their collaboration on inspections of medicine manufacturers
18 July 2018 - Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals ...
Posted by Michael Wonder on 17 May 2018
FDA faster than global peers at approving new drugs
16 May 2018 - A report from the Centre for Innovation in Regulatory Science released this month finds that the ...
Posted by Michael Wonder on 17 Nov 2017
Towards a single development programme for new antibiotics in EU, Japan and US
17 November 2017 - EMA, PMDA and FDA to further align data requirements and explore options to streamline paediatric development. ...
Posted by Michael Wonder on 12 Jun 2017
Regulators in EU, Japan and US take steps to facilitate development of new antibiotics
12 June 2017 - EMA, PMDA and FDA align data requirements and agree on areas of convergence. ...
Posted by Michael Wonder on 27 Nov 2016
Japan drug-pricing reform to get blueprint by year-end
26 November 2016 - The Japanese government will draw up an outline for a comprehensive revision of the country's prescription ...
Posted by Michael Wonder on 24 Nov 2016
USA’s BIO slams Japan’s pharma reimbursement and pricing system
23 November 2016 - The US trade group the Biotechnology Innovation Organization, has declared its disappointment in Japan's price modification ...