France's drug regulatory agency, Afssaps , has published details of the new membership of its various bodies and committees, including those responsible for drug approvals and pharmacovigilance 1 ,2 . The move is noteworthy because the ...
The Kenyan Pharmacy and Poisons Board has issued guidance explaining the current minimum requirements for advertising and promoting drugs and medical devices in the country 1 . The guideline stipulates, among other things, the procedures that ...
Ndjamawe Bah-Traore, Ludwig Hoellein, Johannes Baeumert, Harald G Schweim and Ulrike Holzgrabe describe the results of their survey on the circulation of substandard medicines in sub-Saharan Africa and suggest how regulations in the region might be ...
Mexico's healthcare products regulator, Cofepris , has agreed to expedite the review of certain medical devices that are registered in Japan, under an equivalency agreement 1 . The agreement, which will apply to devices registered in Japan as Class ...
New Zealand's research-based pharmaceutical industry association, Medicines New Zealand, has appointed Heather Roy as its new chair 1 . Mrs Roy will take up the post on 1 February and will replace retiring chair Lex Henry. ?Having spent almost a ...
A new guideline from the European Commission represents the first single, collated document to shed light on the role of the medical device authorised representative, the EU-based person or a body that medical device manufacturers need to have if ...
Gabriel Adusei explains how the IMDRF can build on the achievements of its predecessor, the Global Harmonization Task Force. As the International Medical Device Regulators Forum gears up for its inaugural meeting in Singapore at the end of February ...
A revised version of the international Pharmaceutical Inspection Co-operation Scheme ( PIC/S ) came into effect on 1 January, reflecting several recent changes that have been made to the scheme 1 ,2 . The PIC/S scheme, which was formed to allow for ...
The World Trade Organization 's Committee on Technical Barriers to Trade (TBT) has issued formal notifications of two draft legislation concerning the Brazilian medtech sector 1 ,2 . The notifications are dated 13 January and relate to proposed ...
The US Food and Drug Administration has released the results of a study that was conducted in support of the agency's plans to establish standards for drug sponsors with regard to communicating a medicine's side effects clearly in TV advertisements ...
The US Food and Drug Administration has "in principle" reached an agreement with the medtech industry to establish a faster, more predictable and transparent product review process in return for companies paying more than double the money ($595 ...
