April 2013: The EU Committee on the Environment, Public Health and Food Safety has issued a draft report “On the proposal for a regulation of the European Parliament and the Council on medical devices” which calls for a new authorisation procedure requiring premarket approval prior to sale. In addition, the International Medical Device Regulators’ Forum (IDRF) has released a Non-IVD Market Authorization Table of Contents, intended to support a smooth documentation process for any regulatory submissions. Both of these set to make devices regulation more similar to that for pharmaceuticals.
April 2013: The World Medical Association has proposed altered wording for the Declaration of Helsinki, and released the revised document for public consultation. The new version aims to provide greater protection for vulnerable groups in general, includes a clause regarding compensation, has more detailed requirements for post-study arrangements, a more systematic approach to the use of placebos, and has been restructured in order to aid readability. The document has not increased in length, nor have its core aims changed. The consultation will close on 15th June 2013.
March 2013: The UK government announced on 26th February that in response to the Intellectual Property Office consultation, the law will be changed in order for clinical trials to be performed without the risk of patent infringement. Both the Minister for Universities and Science, and the Minister for Intellectual Property have stated that they feel this will create an environment conducive to pharmaceutical research. The use of patented drugs as a comparator in clinical trials for market authorisations will no-longer be a patent infringement.
March 2013: The FDA has released a Q&A document for comment entitled “M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals Questions and Answers(R2)”. Since the M3(R2) guidance is complex with a broad scope and is significantly different from the M3(R1) guidance, the FDA felt the Q&A document would be useful in order to clarify key issues. The document incorporates changes approved in December 2011 and March 2012.
March 2013: The EMA has updated guidance documents relating to the centralised procedure pre-authorisation, post-authorisation and generic/hybrid products to include information pertaining to orphan medicines. Q&A sections are included for orphan products.
March 2013: The EMA has released standard Paediatric Investigation Plans (PIPs) for acute myeloid leukaemia and rhabdomyosarcoma. The documents identify priority patient subsets and key binding elements for the diseases to encourage development of a PIP. Adhering to the principles of a standard PIP may facilitate the approval process.
March 2013: In order to promote the healthy development of China’s pharmaceutical industry, the State Food and Drug Administration has announced that it intends to implement four areas of reform. They intend to have independent intellectual property rights and expedited drug review process, a revised national strategy for generic drugs, strengthen the quality and management of clinical trials including the use of an independent ethics committee, and also to encourage the development of drugs for children.
March 2013: The Association of the British Pharmaceutical Industry (ABPI) has announced measures intended to help industry comply with the data transparency clauses in its Code of Practice, and also to ensure that they are being met. An independent third party provider will be appointed to ensure compliance, and breaches will be reported to the Prescription Medicines Code of Practice Authority. In addition, a number of tools will be available to encourage greater compliance, including checklists and standard SOP templates, and also workshops hosted by the ABPI.