EMA Consultation: Concept ICH-richtlijn Q12 over technische en regulatoire overwegingen voor levenscyclusbeheer van farmaceutische producten – stap 2b

The European Medicines Agency has released for public consultation a draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management – Step 2b.

This new guideline is proposed to 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 product lifecycle. This guideline aims to promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. The guideline strives to promote, for regulators (assessors and inspectors), an improved understanding of the Applicants’ pharmaceutical quality systems (PQSs) for management of post-approval CMC changes. This new guideline is intended to complement the existing ICH Q8 to Q11 guidelines.

The draft guideline is available by clicking here. Annexes to the draft guideline are also open to public consultation and are available here.

Comments should be provided using this template and sent to ich@ema.europa.eu by 18/12/2018.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.

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