Current Good Manufacturing Practice (cGMP)

Latvia: Cabinet Amends Regulation No. 304 on Medicinal Products Manufacturing and GMP

Latvia has updated its medicinal product manufacturing and GMP regulations, effective April 2026, with a focus on advanced therapy medicinal products (ATMPs). Manufacturers must implement enhanced traceability systems and ensure Qualified Persons meet new specialized training requirements by late 2028 to maintain compliance and market access.

9 Apr 2026, 14:30vestnesis.lvLatvia

EDQM Announces European Pharmacopoeia Issue 13.1 Applicable In 39 Countries From 1 January 2027

The European Pharmacopoeia (Ph. Eur.) Issue 13.1 is now available and will become legally binding across 39 European countries on January 1, 2027. Quality and regulatory teams must assess updated monographs and testing requirements to ensure continued market access and product compliance.

EDQM Publishes Pharmeuropa 38.2 Draft Ph. Eur. Texts For Consultation

The EDQM has opened consultations on 46 new or revised European Pharmacopoeia (Ph. Eur.) standards, covering key active substances and general testing chapters. Businesses should assess these drafts before the June 30, 2026 deadline, as adopted monographs become mandatory quality and safety requirements for pharmaceutical market access in Europe.

Switzerland OSAV Temporarily Authorises Import and Marketing of Bovilis Lumpyvax‑E Lumpy Skin Disease Vaccine

Switzerland has granted temporary market access for the Bovilis Lumpyvax-E vaccine through June 2027 to address Lumpy Skin Disease risks. Companies must navigate rigorous batch-specific approvals and GMP standards, signaling a prioritized but strictly regulated emergency procurement pathway for veterinary products.

2 Apr 2026, 08:49fedlex.data.admin.chSwitzerland

Italy AIFA Revokes Authorisation to Produce Medicinal Gases at La Sanitaria Leucci S.r.l.

The Italian Medicines Agency (AIFA) has revoked the manufacturing authorisation for medicinal gases at La Sanitaria Leucci S.r.l.’s Maglie facility, effective March 2026. Supply chain partners must identify alternative authorized suppliers to ensure continued compliance and market access for medicinal gas products in Italy.

1 Apr 2026, 18:58gazzettaufficiale.itItaly

Brazil ANVISA Suspends Commercialisation, Distribution and Import of 30 In Vitro Diagnostic Devices From Biomolecular Technology

ANVISA has immediately suspended the sale and import of 30 IVD medical devices from Biomolecular Technology due to Good Manufacturing Practice (GMP) violations. Companies must halt distribution of affected lots and review supply chains for blood-glucose monitoring products to ensure compliance and mitigate operational disruption.

1 Apr 2026, 14:19in.gov.brBrazil

Brazil Anvisa Prohibits Irregular Sanitising and Cosmetic Products and Suspends Fort Decap Lots

Brazil's Anvisa has issued Resolution RE No. 1.166/2026, immediately prohibiting several unregistered sanitizing and cosmetic products and suspending specific detergent batches for GMP non-compliance. This enforcement action underscores the critical need for rigorous registration verification and adherence to manufacturing standards to avoid market seizure and brand damage in the Brazilian market.

1 Apr 2026, 14:18in.gov.brBrazil

Kazakhstan — Draft Amendments to QMS Requirements for Medical Devices (G/TBT/N/KAZ/35)

Kazakhstan is proposing a risk-based approach to medical device Quality Management System (QMS) requirements, including potential exemptions from on-site inspections for sterilization processes. This shift toward streamlined compliance oversight may reduce administrative burdens for manufacturers while maintaining focus on high-risk production areas.

28 Mar 2026, 20:29docs.wto.orgKazakhstan

Rhode Island: Amended Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors Rule (216-RICR-40-15-1) Effective 12 April 2026

Rhode Island has finalized comprehensive updates to its pharmacy and pharmaceutical distribution regulations, effective April 2026. Manufacturers and distributors must adapt to modernized compounding standards and new operational frameworks for drug redistribution and clinical service delivery.

28 Mar 2026, 20:28rules.sos.ri.govUnited States

US FDA Outlines Conditions for Using Bulk Drug Substances in Compounding

The US FDA has updated its framework for using bulk drug substances in compounding, clarifying the strict eligibility criteria for 503A and 503B facilities as of March 2026. Businesses must prioritize supplier due diligence and monitor evolving bulk substance lists to mitigate supply chain risks and ensure continued market access for compounded products.

28 Mar 2026, 20:27fda.govUnited States

Australia TGA Opens Consultation On Improving Sunscreen Regulation

Australia’s TGA has launched a consultation to modernize sunscreen regulation, targeting SPF testing reliability, laboratory oversight, and ingredient standards. Manufacturers should prepare for stricter quality assurance requirements, updated GMP guidance, and harmonized labeling rules between therapeutic and cosmetic products.

28 Mar 2026, 20:27tga.gov.auAustralia

Brazilian Chamber CCJ Approves GMP Certification Requirement for Medicine Registration

Brazil's Chamber of Deputies has approved a bill requiring mandatory Good Manufacturing Practice (GMP) certification for all medicine and pharmaceutical input registrations. Companies must prepare for unified registration criteria that prioritize manufacturing quality standards over country-of-origin approvals, streamlining compliance for both domestic and imported products.

28 Mar 2026, 17:06camara.leg.brBrazil

European Pharmacopoeia Commission Creates cMEP Working Party for Rapid Microbiological Methods Certification

The European Pharmacopoeia Commission has launched a new working party to formalize a certification framework for rapid microbiological methods (cMEP). This move toward harmonized validation standards will streamline the adoption of faster quality control technologies, impacting long-term manufacturing efficiency and compliance strategies for sterile products.

Colombia: Draft Resolution On GMP Manuals For Herbal Products

Colombia has proposed new Good Manufacturing Practice (GMP) manuals and inspection protocols for herbal products, including sterile preparations, to standardize quality controls for domestic and imported goods. Manufacturers and importers must prepare for stricter compliance oversight and potential operational adjustments to meet these formalized quality management and inspection standards.

27 Mar 2026, 20:40members.wto.orgColombia

US FDA Publishes FY 2025 Drug Quality Sampling And Testing Results

The US FDA has released its FY 2025 drug quality surveillance results, confirming high compliance rates across tested pharmaceuticals with only one specific dissolution failure identified. This update signals the FDA's continued reliance on risk-based post-market testing to drive enforcement and quality improvements, necessitating rigorous supply chain oversight for manufacturers and distributors.

27 Mar 2026, 20:09fda.govUnited States

US FDA Issues Form 483 to Micro Labs Limited (India) for Data Integrity and Equipment Cleaning Deficiencies

The US FDA issued a Form 483 to Micro Labs Limited (India) following an inspection that revealed systemic data integrity failures and inadequate equipment cleaning protocols. These findings signal significant quality management risks, potentially leading to supply chain disruptions or escalated enforcement actions for firms sourcing finished drug products from this facility.

27 Mar 2026, 18:42fda.govUnited StatesIndia

US FDA Class I Recall Of Erbe Flexible Cryoprobes

The US FDA has upgraded the recall of Erbe flexible cryoprobes to Class I, its most serious designation, following reports of device ruptures and serious injuries. This enforcement action necessitates immediate inventory quarantine and highlights the critical need for robust manufacturing quality controls to prevent catastrophic failure in pressurized medical devices.

27 Mar 2026, 18:37fda.govUnited States

Chile Ministry of Health Adopts Decree Bringing Selected Medical Devices and IVDs Under Sanitary Control

Chile has mandated formal sanitary registration and conformity assessment for 39 categories of high-risk medical devices and IVDs, effective March 2026. Manufacturers must align quality systems with ISO standards and secure ISP registration within two to three years to maintain market access for critical healthcare products.

27 Mar 2026, 18:17diariooficial.interior.gob.clChile

US FDA: Amneal Recalls One Lot of Magnesium Sulfate 4 g/100 mL IV Bags After Mix-Up With Tranexamic Acid

Amneal Pharmaceuticals has issued a voluntary nationwide recall for a specific lot of Magnesium Sulfate IV bags following a product mix-up with Tranexamic Acid. This enforcement action underscores the critical importance of packaging integrity and cGMP compliance to mitigate severe patient safety risks and potential liability in the pharmaceutical supply chain.

27 Mar 2026, 07:52fda.govUnited States

US FDA Issues CGMP Warning Letter to Yangzhou H&R Plastic Daily Chemical Co., Ltd.

The US FDA has issued a Warning Letter and placed Yangzhou H&R Plastic Daily Chemical on Import Alert following significant pharmaceutical manufacturing quality violations. Impacted firms must immediately assess supply chain exposure, as the detention of goods and withholding of new product approvals will persist until comprehensive remediation is verified.

27 Mar 2026, 07:01fda.govUnited States