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News

Regulatory News and Updates

April/May Latest Headlines

GMP - MUTUAL RECOGNITION AGREEMENT WITH THE USA

EU Mutual Recognition agreements – see section on the USA. In transition until July 2019. Now 24 Member States are recognised to perform inspections on behalf of the FDA.
https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/mutual-recognition-agreements-mra

Update: Questions and answers on the impact of mutual recognition agreement between the European Union and the United States as of 30 April 2019
https://www.ema.europa.eu/documents/other/questions-answers-impact-mutual-recognition-agreement-between-european-union-united-states-30-april_en.pdf

Two additional countries to benefit from EU-US mutual recognition agreement for inspections
https://www.ema.europa.eu/en/news/two-additional-countries-benefit-eu-us-mutual-recognition-agreement-inspections-0

GMP FOR STERILE CONTAINERS [from gmp-compliance.org]
https://www.gmp-compliance.org/gmp-news/gmp-for-sterile-containers

USP
New Drafts for General Chapters on Plastic Materials
https://www.gmp-compliance.org/gmp-news/usp-published-new-drafts-for-general-chapters-on-plastic-materials

EU VARIATIONS

Update – EMA Classification of changes: questions and answers
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/classification-changes-questions-answers

Update - Extensions of marketing authorisations: questions and answers
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/variations/extensions-marketing-authorisations-questions-answers

PHARMACOVIGILANCE

Update: Regulatory and procedural guideline: EudraVigilance registration manual
https://www.ema.europa.eu/documents/regulatory-procedural-guideline/eudravigilance-registration-manual_en.pdf

Update:  List of EU reference dates and frequency of submission of periodic safety update reports
https://www.ema.europa.eu/documents/other/list-european-union-reference-dates-frequency-submission-periodic-safety-update-reports_en-0.xls

Update – EMA Q&A on risk management plan – addition of Q16 relating to RMPs for generic products where the ref product has an RMP.
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/risk-management-plan-rmp-questions-answers

MANUFACTURING

EMA Guide on Sterilisation for Medicinal Products, API Excipients and Primary Packaging
https://www.gmp-compliance.org/gmp-news/ema-guide-on-sterilisation-for-medicinal-products-api-excipients-and-primary-packaging-published

CLINICAL

Q&A on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation
https://ec.europa.eu/health/sites/health/files/files/documents/qa_clinicaltrials_gdpr_en.pdf

Update: Q&A on the EMA policy on publication of clinical data for medicinal products for human use
https://www.ema.europa.eu/documents/report/questions-answers-european-medicines-agency-policy-publication-clinical-data-medicinal-products_en.pdf

BREXIT

Update – EMA European authorities working to avoid shortages of medicines due to Brexit – Questions and answers
https://www.ema.europa.eu/documents/other/european-authorities-working-avoid-shortages-medicines-due-brexit-questions-answers_en.pdf

EU PROCEDURES

Update – EMA post-authorisation procedural advice for users of the centralised procedure
https://www.ema.europa.eu/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en-0.pdf

FDA PROCEDURES

FDA issues Final Guidance for Industry on Determining Whether to Submit an ANDA or 505(b)(2) Application
https://www.fda.gov/media/124848/download?utm_campaign=FDA%20issues%20Final%20Guidance%20for%20Industry%20on%20Determining%20Whether%20to%20Submit%20an&utm_medium=email&utm_source=Eloqua

FDA Issues Final Guidance on the Q-Submission Program for Medical Device Submissions
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program?utm_campaign=2019-05-06%20Guidance%20Webinar%20-%20Q-Submission%20Program%20for%20Medical%20Device%20Submissions&utm_medium=email&utm_source=Eloqua

Ian Abernethy