The ICH Steering Committee (SC) and twelve ICH Expert Working Groups met in Fukuoka, Japan from June 5 -11, 2015.
The SC agreed on the key issues relating to the reform of ICH in terms of the Articles of Association, funding model and membership. The new ICH Association under Swiss law is expected to be established over the coming months with the aim of being operational starting in 2016.
The Addendum of the ICH M7 Guideline Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached Step 2b of the ICH Process in June 2015 and is now entering the consultation period (Step 3).
Last week the European Commission officially added Israel and Brazil to the list of third countries outside the European Union that have manufacturing standards and supervision of APIs equivalent to those of the EU.
The illegal sale of medicinal products to the public has increased dramatically. Mostly they are distributed via Internet. To better protect consumers, as of 1 July 2015, a new common EU logo helps to identify the websites which are operating legally. The logo links to the website of the national competent authority and can be trusted, if the operating online pharmacy/retailer is listed. A press release of the British MHRA shows the necessity of such protective measures:
Dangerous counterfeit and unlicensed medicines worth £ 15.8 million have been seized in a record haul by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) as part of ‘Operation Pangea VIII’. The seizures are a result of a crackdown on the illegal internet trade of medical products that yielded £ 51,6 million worth of items from 115 different countries globally. The majority of the products seized originated from India, China, Hong Kong and Singapore.
The ICH has published the final version of the Q&A document to the ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. The document was prepared by the Q7 Implementation Working Group in order to clarify uncertainties related to the interpretation of some sections.
As previously announced by the ICH, new training material to ICH documents will be published and updated on the ICH website on a regularly basis. The intention behind this supporting service is to facilitate the implementation of ICH Guidelines by resolving uncertainties which have arisen during the application of the guideline.
The WHO has published the final versions of the
Both documents were released as part of the Technical Report Series 992, which was published by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in May 2015.
The EMA has released a concept paper on new guidance for importers of medicinal products. GMP/GDP Inspectors Working Group agreed to draft a specific guidance for import authorisation holders. This document most likely would take the form of a new annex (Annex 21). The deadline for comments is 29 August 2015.
The ICH Steering Committee (SC) will meet in Fukuoka, Japan from 6 to 11 June to discuss ongoing harmonisation activities. One item on the agenda is the development of the ICH Q12 Guideline on Lifecycle Management.
The IPEC Federation (International Pharmaceutical Excipients Council) has published a three-page position paper concerning the risk-based approach of the EU Guidelines following the principles of Quality Risk Management according to ICH Q9. The IPEC-paper applies to the community regulated under the EU Risk Assessment Guidelines.
The European Commission has published the responses to the public consultation on the revision of Annex 15: Qualification and Validation.