Guidelines
US guidelines for generics
Last update: 1 August 2011
The regulatory body for approval of medicines in the US is the FDA.
FDA to release guidance on generic tablet size
The FDA hopes to release guidance in the next few months to help generic drug makers understand how big or small their tablet or capsule can be compared to the branded equivalent, an agency official said.
Canadian guidelines for biosimilars
The regulatory body for approval of medicines in Canada is the Therapeutic Products Directorate of Health Canada.
Health Canada develops and enforces regulations under Canadian governmental legislation.
Canadian guidelines for generics
The regulatory body for approval of medicines in Canada is the Therapeutic Products Directorate of Health Canada.
Health Canada develops and enforces regulations under Canadian governmental legislation.
Japanese guidelines for biosimilars
Last update: 07 June 2011
The Ministry for Health Labour and Welfare (MHLW) is the regulatory body in Japan responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Japan and makes the decision on approval of drugs, including biologicals.
FDA issues new bioequivalence guidance for generics
In May 2011, the FDA issued new guidance for the submission of summary bioequivalence data for abbreviated new drug applications (ANDAs). This new guidance means that all bioequivalence data will now have to be submitted, including failed studies.
EMA, FDA and TGA joint GMP inspection programme
On 27 April 2011, the FDA announced that it is working with the EMA and Australia’s Therapeutic Goods Administration (TGA) to finalise a permanent pilot programme for joint good manufacturing practice (GMP) inspections at active pharmaceutical ingredient (API) manufacturing facilities.
FDA and EMA to join forces on quality
EMA and FDA have launched on 1 April 2011 a three-year pilot programme to allow parallel evaluation of quality elements, known as Quality by Design (QbD), of selected applications submitted to both agencies at the same time.
China’s regulatory authority adopt CTD format for NDAs
On 25 September 2010, China’s State Food and Drug Administration (SFDA) issued new guidance for industry for submission of new drug applications (NDAs) in the common technical document (CTD) format.
EMA adopts guideline on biosimilar monoclonal antibodies
EMA announced on its website that it has adopted the long-anticipated guideline on biosimilar monoclonal antibodies.