EMA has published the work plan of the GMP/GDP Inspectors Working Group for 2015. The plan covers the different tasks of the group, e.g. harmonisation of inspections, mutual recognition agreements (MRAs) (maintenance, extension of scope) and GMP/GDP topics.
The list of GMP documents for revision contains the usual suspects – like Annex 15, but also the totally new Annex 21 on importation of medicinal products.
The U.S. Food and Drug Administration (FDA) issued five draft documents related to drug compounding and repackaging to help entities in complying with important health provisions. The draft documents apply to outsourcing facilities, federal facilities, pharmacies and physicians. The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013.
New versions of Chapter 3 (Premises and Equipment) and Chapter 5 (Production) have been published providing transitional arrangements for toxicological evaluation. The chapters are otherwise unchanged – apart from an editorial correction of footnote 2 in Chapter 5 – and become operational on 1 March 2015 for all other aspects.
China’s Food and Drug Administration (CFDA) has issued the country’s first Good Supply Practices (GSP) regulations that apply to all Class 1, 2 and 3 medical device distributors, as well as third-party logistics service providers for medical devices.
China’s Food and Drug Administration (CFDA) has revised the Good Manufacturing Practice for Medicinal Devices in accordance to the newly revised Regulations for the Supervision and Administration of Medical Devices and Administrative Measures for the Supervision of Medical Device Manufacturing.
FDA Center for Drug Evaluation and Research (CDER) launched an Office of Pharmaceutical Quality (OPQ) as part of its ongoing Quality Initiative. This new office plans to create a drug quality program as the programs the agency already has in place for drug safety and efficacy.
The ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH Process in December 2014 and now enters the implementation period (Step 5). The new guidance has been developed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.
The US Food and Drug Administration (FDA) has just released a list of all new and revised draft guidances it plans to release in 2015. The list is published on an annual basis by FDA's CDER.
The ICH Steering Committee (SC) and its Expert Working Groups (EWGs) met in Lisbon, Portugal on November 8–13, 2014. The meeting was hosted by the European Commission and included over 300 participants.
Before the end of the year the European Commission has published the “Commission Delegated Regulation (EU) No. 1252/2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use”. The regulation was issued on 25 November 2014 in the Official Journal of the European Union and has entered into force on 15 December 2014.
The regulation is binding in its entirety and directly applicable in all Member States of the European Union.
The EMA has published the final version of the „Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”. The document was long expected and aims to recommend an approach for deriving a scientifically based threshold value for individual active substances to be applied for risk identification.
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal product) in the EEA. The EMA has published a revised version of the guideline "Guideline on similar biological medicinal products". It outlines the general principles to be applied for similar biological medicinal products (also known as biosimilars) as referred to in Directive 2001/83/EC and includes the following categories:
Officials of Australia and New Zealand have confirmed the plan to stop the development of the joint regulatory authority ANZTPA. The decision was taken following a comprehensive review of progress and assessment of the costs and benefits to each country.