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Category: Regulatory Updates

The Regulatory Updates category provides timely coverage of new guidelines, draft revisions, and official communications from authorities such as the EMA, FDA, ICH, USP, and Ph. Eur. It highlights regulatory changes that affect GMP operations, product development, and quality systems.

Each update is presented with context, showing what it means for manufacturers, QA/RA professionals, Qualified Persons, and supply chain leaders. Topics range from revisions to GMP chapters and data integrity expectations to draft guidance on testing and validation.

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Featured image for a GMP Insiders news article on EMA’s revised Shortage Prevention Plan framework, showing a pharmaceutical supply warehouse with stocked pallets. The update introduces new risk thresholds, market-share criteria, and a two-day SPP submission requirement.

EMA Revises the Shortage Prevention Plan Risk Assessment Ahead of the Mid-2027 Legal Deadline

EMA has revised its Shortage Prevention Plan guidance, introducing new risk assessment criteria, market-share thresholds, supply chain classifications, and a...
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eatured image for a GMP Insiders news article on the proposed Ph. Eur. GC method for macrogols, showing gas chromatography laboratory equipment. The EDQM proposal introduces a redesigned GC procedure and new controls for ethylene glycol and diethylene glycol in Macrogols (1444).

Ph. Eur. Proposes a New Gas Chromatographic Control for Ethylene Glycol and Diethylene Glycol in Macrogols (1444)

Ph. Eur. proposes a new capillary GC method and tighter limits for ethylene glycol and diethylene glycol in Macrogols (1444)....
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Featured image for a news article about the new PIC/S Qualification and Validation Guidance (PI 006-4), highlighting major updates to process validation, cleaning validation, equipment qualification, and quality risk management effective from August 2026.

PIC/S Issues PI 006-4 on Qualification and Validation, Effective 1 October 2026

PIC/S PI 006-4 introduces major updates to qualification and validation, including process validation, cleaning validation, qualification, data integrity, and quality...
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Featured image for a GMP Insiders news article on EMA's Q&A guidance for microbial contamination control in non-sterile medicinal products. The graphic shows regulatory documents clipped together, representing new EMA expectations for contamination control, cleaning validation, and quality risk management in pharmaceutical manufacturing.

EMA Issues Q&A Guidance on Technical and Organizational Controls for Microbial Contamination in Non-Sterile Medicinal Products

The European Medicines Agency has published a new Q&A clarifying GMP expectations for preventing microbial contamination in non-sterile medicinal products....
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Featured image for a GMP Insiders news article on Pharmeuropa 38.3 showing a document being officially stamped, highlighting proposed European Pharmacopoeia draft revisions for microbiological quality, pesticide residues, and delivered dose testing.

Pharmeuropa 38.3: Proposed Ph. Eur. Updates for Microbiological Quality, Pesticide Residues and Delivered Dose Testing

Pharmeuropa 38.3 introduces proposed European Pharmacopoeia revisions affecting microbiological quality, pesticide residues, and delivered dose testing. This article explains the...
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FDA revises Preapproval Inspection (PAI) Compliance Program 7346.832, featured image showing regulatory documents and inspection records representing FDA risk-based pharmaceutical inspections.

FDA Rewrites Its Preapproval Inspection Playbook: Revised Compliance Program 7346.832

FDA's revised Compliance Program 7346.832 changes how Preapproval Inspections (PAIs) are planned, scoped, and conducted using a more risk-based inspection...
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Revised EU GMP Annex 19 published, with a regulatory document being stamped and the subtitle on reference and retention samples before September 2026.

Revised EU GMP Annex 19: What Changes for Reference and Retention Samples?

The 2026 revision of EU GMP Annex 19 introduces focused updates for reference and retention samples, mainly affecting parallel trade,...
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Draft USP–NF PF 52(3): Proposed Updates to Glass Container and Solubility General Chapters

USP’s PF 52(3) drafts propose important updates to glass container chapters 〈660〉 and 〈1660〉, including new glass families, modernized identification...
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Featured image for Pharmeuropa 38.2 draft updates showing regulatory documents and GMP Insiders branding.

Pharmeuropa 38.2: New Drafts Released for Public Consultation

Pharmeuropa 38.2 introduces draft revisions to bacterial endotoxin testing, particle-size analysis, and sieve chapters, with comments open until 30 June...
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GMP Insiders feature image for an article on FDA final Q3 guidance for topical ANDAs, showing a stack of regulatory documents beside the headline text.

FDA Issues Final Guidance on Q3 Characterization of Topical Drug Products in ANDAs

FDA’s final Q3 guidance for topical ANDAs clarifies how physicochemical and structural characterization supports dosage form assessment and bioequivalence....
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