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.
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.
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.
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 announced on its website that it has adopted the long-anticipated guideline on biosimilar monoclonal antibodies.
On 28 October 2010, India’s Central Drugs Standard Control Organization (CDSCO) released new guidance for industry for submission of new drug applications (NDAs) in the common technical document (CTD) format.
In an effort to improve safety detection, the FDA issued a final rule and draft guidance on 29 September 2010 to clarify the requirements governing safety reporting requirements for human drug and biological products subject to an investigational new drug (IND) application.
In his opening address to the 8th EGA International Symposium on Biosimilar Medicines held in London on 2–3 September 2010, EGA Director General Mr Greg Perry praised the EU for inspiring the rest of the world regarding development of biosimilar guidelines.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has guidelines that provide a framework for the development of ‘biosimilars’ in the EU. The recent licensing of recombinant somatropins and several erythropoietins has proved that the present system works. Can the same regulatory path also be applied to more complex biologicals, such as monoclonal antibodies (mAbs)?
The US FDA is authorised to perform inspections under the Federal Food, Drug, and Cosmetic Act. The FDA Form 483 is a form used by the FDA to document and communicate concerns discovered during these inspections and to list items that deviate from Good Manufacturing Practices.