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.
This month representatives of the FDA have met with their cross-agency team from the EMA, the European Commission and GMP experts form European Union Member States in London, in order to make progress on mutual reliance on GMP inspections. The event was the first face-to-face meeting of both complete teams to discuss how EMA and FDA can collaborate in the field of inspections.
The FDA has published the following two updated lists of guidelines:
ISPE released its Drug Shortages Prevention Plan during the 2014 Annual Meeting in Las Vegas, Nevada. ISPE developed the plan in response to global regulatory interest in preventing drug shortages due to manufacturing and quality issues. The plan addresses shortages at both the product and process levels. It lays out how industry can best prevent drug shortages by identifying the root causes of supply disruptions and creating a quality culture that will ensure a robust, resilient and reliable supply of medications to patients worldwide.
MHRA just published inspection trend data from 2013. The report has been presented in a revised format, following comments from a stakeholder focus group. In addition to 2013 inspection deficiency data, the report also includes longer term trends in ‘top 10 deficiencies’ and highlights areas for continued focus.