Key GMP Focal Points in Europe Include Guidance Revisions, New Vet Regulations, and Adaptive Assessment/Inspection Approaches

INTRODUCTION

Key focal points in the European GMP arena include revisions to guidance, new veterinary medicine regulations, and adapting assessment/inspection processes to enable manufacturing through the COVID pandemic, foster international collaboration, and address point-of-care manufacturing.

The PDA Europe Quality and Regulations Conference, held virtually in late October, provided regulator and industry experts the opportunity to share updates on the GMP/inspection policy development initiatives in which they are engaged. This three-part story builds on the discussions at that conference.

● Part I: Update on EMA GMP-related Activities

Leading off the opening session with an overview of GMP activities in 2021 and anticipated EU releases was EMA Lead Scientific Officer Brendan Cuddy. With the benefit of his insights, the first part of the story reviews: ● a revision of EU GMP Annex 1 on manufacturing of sterile medicinal products and a new Annex 21 on importation of medicinal products, both expected to be released in Q1 2022 ● recent EU regulation and guidance developments in the veterinary product arena and their human drug GMP implications, and ● regulatory flexibilities flowing from the pandemic. Other recent developments highlighted include a currently running EMA survey on its plans to create a Quality Innovation Group.

● Part II: MHRA Innovation Pathway and Proposal for Point-of-Care Regulatory Framework

Following Cuddy at the opening session was UK MHRA’s Lead Senior GMDP Inspector Philip Rose, who provided an update on the agency’s Innovative Licensing and Access Pathway (ILAP), “adaptive” inspection, and point-of-care (POC) initiatives. Provided is an in-depth review of the formative proposal MHRA has developed for a new regulatory framework to address the unique challenges of POC manufacturing. Included are insights from key MHRA thought leaders that have been involved in the MHRA and international efforts to make the regulatory accommodations to product and process advancement.

● Part III: Insights from EDQM, EFPIA, PDA and ICMRA on Inspection Alternatives

The third part of the story shifts attention onto the PDA conference session that followed, in which regulator and industry perspectives were offered on the experiences and learnings from “alternatives to on-site inspections.” Participants included representatives from the Russian agency, EDQM, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and a PDA working group on remote inspections. Reviewed are the reports that have been flowing from these groups on the experience and learnings with the manufacturing assessment adaptations. Also spotlighted is an important reflection paper released in December by the International Coalition of Medicines Regulatory Authorities (ICMRA) summarizing the pandemic experience and learnings from the regulator vantage point.

[CLICK HERE for the complete story as the three parts are made available.  Nonsubscribers can get information on individual IPQ subscriptions and organization-wide licenses by contacting Karen Bertani (Jonathan@ipq.org).]