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.
This month the EMA released a “Reflection paper in the requirements for selection and justification of starting materials for the manufacture of chemical active substances”. It aims to clarify some of the expectations of EU competent authorities arising from the guidance found in ICH Q11 regarding the information to be submitted in marketing authorisation dossiers to justify the selection of starting materials.
On 21 October 2014, the FDA released the final version of its Guidance for Industry entitled „Circumstances that constitute delaying, limiting, or refusing a drug inspection”. Delaying, refusing, denying – FDA inspectors often see themselves confronted with cooperation problems. The guidance intends to clarify how the law under Section 707 of FDASIA (Food and Drug Administration Safety and Innovation Act) will be interpreted and put into practice by the FDA.
The ICH Steering Committee has endorsed the final concept paper Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”. According to the ICH this new document shall provide guidance on a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the lifecycle of a product.
The World Health Organization (WHO) has published the revised draft of the Supplementary Guideline on Good Manufacturing Practices: Validation Appendix 7: Non-sterile Process Validation.
A new webpage has just been launched under the Certification of Suitability section of the website.
The application forms for requests for certificates of suitability (CEPs) have been updated.