Current Good Manufacturing Practice (cGMP)

US FDA Requests Comment on CGMP and Advanced Manufacturing Information Collection for Drugs

In May 2026, the US Food and Drug Administration submitted to OMB a revised information-collection request for CGMP recordkeeping covering active pharmaceutical ingredients, finished pharmaceuticals, voluntary consensus standards and the Advanced Manufacturing Technologies designation program. The notice does not change underlying CGMP requirements but confirms substantial ongoing documentation burdens, removes medical gas-related obligations to a separate collection, and opens a 30-day comment window that manufacturers and advanced manufacturing applicants may use to shape future reporting expectations.

22 May 2026, 17:11public-inspection.federalregister.govUnited States

US FDA Issues CGMP Warning Letter to JW Nutritional LLC Over OTC Drug Manufacturing

In April 2026, the US FDA issued a CGMP warning letter to contract manufacturer JW Nutritional LLC over serious quality and microbiological control failures affecting OTC drug products. The findings and short corrective timelines signal stricter enforcement expectations for OTC manufacturers on raw-material testing, process and water-system validation, and robust microbial specifications, with potential recalls and supply disruptions if issues are not resolved.

20 May 2026, 19:56fda.govUnited States

US FDA Issues CGMP Warning Letter to Hangzhou Yiqi Biotechnology Co., Ltd (WL 720707)

In April 2026 the US FDA issued a CGMP warning letter to Chinese API manufacturer Hangzhou Yiqi Biotechnology Co., Ltd after determining its APIs are adulterated under the Federal Food, Drug, and Cosmetic Act and confirming they are subject to Import Alert 66-40. Drug sponsors and supply-chain partners relying on this facility for sterile or compounded APIs should reassess sourcing and oversight, given the risk of shipment refusal and delayed approvals until CGMP deficiencies are fully remediated and verified by FDA.

20 May 2026, 19:55fda.govUnited States

US FDA Updates Medical Device Inspection Program 7382.850 and Retires QSIT

In May 2026 the US FDA published an updated compliance program for inspecting medical device manufacturers that retires the QSIT model and implements a QMSR-aligned, risk-based inspection framework effective 2 February 2026. Medical device companies should reassess their quality systems, internal audits, and inspection readiness to ensure alignment with ISO 13485-based QMSR expectations across design controls, postmarket surveillance, tracking, and UDI traceability.

14 May 2026, 19:09fda.govUnited States

APIC Position Paper Advocates Risk-Based Use of Recycled Solvents in API Production

APIC, the Cefic sector group for API manufacturers, has issued a position paper urging regulators and industry to maintain and expand a risk-based acceptance of recycled solvents in API production while it prepares detailed industry guidance on how to justify and control their use. This highlights growing tension between sustainability and increasingly risk-averse draft regulations, signalling that companies should anticipate new best-practice expectations around solvent recycling, quality specifications, and risk assessments in GMP-regulated manufacturing.

14 May 2026, 08:11apic.cefic.orgEuropean Union

US FDA Issues CGMP Warning Letter to ABBE Laboratories, Inc. For OTC Drug Manufacturing Violations

US FDA has issued a warning letter to ABBE Laboratories, Inc. for significant CGMP violations in its OTC drug manufacturing, following a February 2025 inspection and setting short response deadlines. This enforcement action increases regulatory and quality risk for the company’s OTC portfolio and underscores FDA’s focus on high-risk excipients, process validation, and robust quality systems.

12 May 2026, 15:40fda.govUnited States

EMA Workshop To Shape Risk-Based AI Guidance For GMP Annex 22

EMA’s GMP/GDP Inspectors Working Group will hold a two-day multistakeholder workshop on 30 June–1 July 2026 to gather expert evidence for Annex 22 EU guidance on the use of generative AI in medicines manufacturing. The workshop signals that regulators are actively exploring risk-based guardrails that could eventually permit certain AI systems in critical GMP applications, so pharmaceutical manufacturers should track outcomes as they may shape future Annex 22 expectations.

9 May 2026, 19:12ema.europa.euEuropean UnionNetherlands

Ukraine Proposes GMP Compliance Confirmation Procedure for Foreign Medicinal Product and API Manufacturers

Ukraine has notified a draft order establishing a new GMP compliance confirmation procedure for human medicinal product and API manufacturing sites located outside Ukraine, with consultation open until 19 June 2026. Pharmaceutical companies using foreign manufacturing for the Ukrainian market should prepare for more formalised evidence requirements and potential inspections, and assess whether their sites’ existing SRA GMP documentation will satisfy the forthcoming rules.

8 May 2026, 07:00members.wto.orgUkraine

US FDA Issues CGMP Q&A on Production and Process Controls

FDA has published an updated nonbinding Q&A guidance on 05 May 2026 that consolidates and clarifies current good manufacturing practice (cGMP) expectations for drug production and process controls, including validation strategy, aseptic processing, microbial control, preservative use, ophthalmic sterility, and cell and gene therapy PPQ. Drug manufacturers should benchmark their quality systems, validation protocols, and contamination-control strategies against these interpretations of 21 CFR parts 210 and 211 to reduce enforcement risk and strengthen assurance of product sterility and quality.

8 May 2026, 06:58fda.govUnited States

EMA Updates “Quality of Medicines” Questions and Answers – Part 2

In May 2026, EMA’s Quality Working Party updated Part 2 of its Quality of medicines Q&A guidance, issuing new positions on tablet appearance, in-use stability, active-substance mixing, titanium dioxide use and skip testing. These clarifications will influence how pharmaceutical companies design formulations, packaging, stability studies, excipient strategies and variation plans to stay aligned with current EU expectations for medicine quality and manufacturing compliance.

8 May 2026, 06:49ema.europa.euEuropean Union

Taiwan TFDA Promotes Voluntary GMP System for Health Supplements

Taiwan’s Food and Drug Administration is promoting a voluntary GMP system for health supplement manufacturers, built on 2020 guidelines and inspection-based certification to align production with international standards. While not legally mandatory, this scheme creates a de facto quality benchmark for Taiwanese supplement suppliers and can support market access and risk assurance for overseas customers relying on documented manufacturing controls.

5 May 2026, 06:46fda.gov.twTaiwanMalaysiaVietnamPhilippinesIndonesia

US FDA Issues Form 483 to Excelvision (France) for Aseptic Processing and Complaint Investigation Deficiencies

In November 2024 the US FDA inspected Excelvision’s sterile drug manufacturing facility in France and issued a Form 483, later followed by a May 2025 warning letter, citing serious deficiencies in complaint handling, aseptic processing, cleaning, and environmental monitoring for sterile drugs supplied to the US market. These findings signal elevated CGMP enforcement risk for this site, potential disruption or tighter scrutiny of sterile drug supply to the US, and a need for robust remediation and oversight by customers relying on this facility.

3 May 2026, 09:22fda.govFranceUnited States

EU Council/Coreper Schedules Adoption of CETA GMP Mutual Recognition Decision on Active Pharmaceutical Ingredients

The EU Council is advancing towards adoption of its position in the CETA Joint Committee on adding active pharmaceutical ingredients to the GMP mutual recognition annex, with the item now listed for adoption at Coreper. If the Council and CETA Joint Committee complete this step, mutual recognition of GMP compliance would extend to APIs, signalling reduced regulatory friction for EU and Canadian pharmaceutical supply chains and warranting close monitoring by quality and trade teams.

3 May 2026, 09:10data.consilium.europa.euEuropean UnionCanada

China NMPA Issues Guiding Principles Requiring 5-Year Inspections of Pharmaceutical Excipients and Packaging Materials

China’s National Medical Products Administration has issued guiding principles for inspecting GMP appendices on pharmaceutical excipients and packaging, requiring provincial regulators to inspect “A” status manufacturers at least once every five years and to standardise how inspections are planned, executed, and reported. This will tighten oversight of excipient and packaging supply chains supporting medicines in China, increasing visibility of GMP compliance and inspection findings for marketing authorisation holders and regulators and potentially raising expectations for documentation and quality systems at upstream suppliers.

3 May 2026, 09:09nmpa.gov.cnChina

US FDA Issues CGMP and Misbranding Warning Letter to Foshan Miwei Cosmetics Co., Ltd.

The US FDA has issued a CGMP and misbranding warning letter to Chinese manufacturer Foshan Miwei Cosmetics covering OTC sunscreen drug products Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer, with all drug imports from the facility already subject to Import Alert 66-40. Companies sourcing private-label sunscreens or other OTC drugs from this site should expect shipments to be detained, reassess product quality and labeling against US OTC monograph requirements, and prepare for additional testing, recalls, or supplier changes if FDA finds corrective actions inadequate.

3 May 2026, 07:33fda.govUnited States

US FDA Issues CGMP Warning Letter to Lexia LLC Over OTC Topical Pain Relief Drug

In April 2026, the US FDA issued a CGMP warning letter to Lexia LLC’s Franklin, Tennessee facility for serious deficiencies in manufacturing an OTC topical pain relief drug, deeming its products adulterated under the Federal Food, Drug, and Cosmetic Act. Although Lexia has already ceased OTC drug production and deregistered as a drug manufacturer, it must remediate core quality systems and meet tight FDA response deadlines before any future operations, signalling continued enforcement pressure on smaller drug and cosmetic manufacturers.

3 May 2026, 07:33fda.govUnited States

US FDA Issues CGMP Warning Letter to Intas Pharmaceuticals Limited (WL 721151)

In March 2026, the US Food and Drug Administration issued a CGMP warning letter to Intas Pharmaceuticals Limited’s Dehradun facility after a 2025 inspection found serious assay investigation failures and electronic batch-record data integrity issues affecting finished drug products. The action heightens enforcement and import-refusal risk for products from this site and pressures Intas to overhaul its investigation, CAPA, and quality-governance systems to protect US supply continuity and patient safety.

3 May 2026, 07:33fda.govUnited States

Australia TGA Clarifies Licensing Requirements and Planned GMP Exemption for Bacteriophage Products

Australia’s Therapeutic Goods Administration has issued detailed guidance confirming that most domestic manufacture of bacteriophage therapy products requires a TGA manufacturing licence, with only narrow exemptions for experimental use and tightly defined hospital-based manufacture and a planned three-year GMP exemption not yet in force. Manufacturers and hospital facilities exploring bacteriophage production should assume full licensing and GMP compliance as the baseline while monitoring for the 2026 legislative amendment that may temporarily ease requirements for small-batch, patient-specific therapies.

1 May 2026, 17:28tga.gov.auAustralia

Draft CETA Joint Committee Decision (Corrigendum) on Adding Medicinal Active Substances to GMP Mutual Recognition Protocol

The EU has published a draft CETA Joint Committee decision to extend the EU–Canada GMP mutual-recognition protocol to cover medicinal active substances listed in Annex 1. If adopted, this will tighten EU–Canada regulatory alignment on active pharmaceutical ingredient manufacturing and is likely to reduce duplicate GMP inspections and ease market access for qualifying EU and Canadian sites.

30 Apr 2026, 06:51eur-lex.europa.euEuropean UnionCanada

Japan MHLW Consults on Ordinance Revisions Implementing PMD Act Amendments for Pharmacies and Remote OTC Sales

Japan’s Ministry of Health, Labour and Welfare has issued draft ordinances to implement 2025 amendments to the Pharmaceuticals and Medical Devices Act, overhauling pharmacy certification, GMP inspections, partial outsourcing of dispensing, remote OTC medicine handover, and some CSCL inspection documentation, with public comments due by 23 May 2026. Pharmaceutical manufacturers, distributors, pharmacies, and OTC retailers in Japan should assess how the proposed models for health promotion pharmacies, outsourced dispensing, and remote sales will affect licensing, quality systems, and digital record-keeping ahead of expected promulgation around mid-2026.

30 Apr 2026, 06:24public-comment.e-gov.go.jpJapan