Clinical Trials

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

US DEA Seeks Comment on MDMA Importer Registration for Fisher Clinical Services, Inc.

The US DEA is reviewing an application from Fisher Clinical Services to import MDMA for clinical trial use, with a public comment deadline of May 1, 2026. This move reflects the ongoing regulatory pathway for psychedelic substances in medical research, signaling continued federal oversight of supply chains for restricted compounds.

4 Apr 2026, 10:55federalregister.govUnited States

Estonia Establishes Fast-Track Clinical Trial Assessment Procedure and Joins FAST-EU Pilot

Estonia has launched a national fast-track assessment for Phase I/II clinical trials and joined the EU-wide FAST-EU pilot to accelerate drug development timelines. Pharmaceutical and biotech firms can now leverage shorter 30–40 day review windows in Estonia, signaling a broader European shift toward more competitive and streamlined market entry for innovative medicines.

2 Apr 2026, 16:59ravimiamet.eeEstoniaEuropean Union

EU Commission Adopts Implementing Decision (EU) 2026/193 Updating Harmonised Standards For Medical Devices

The EU Commission updated the list of harmonised standards for medical devices under the MDR in January 2026, covering critical areas like sterilization and biological evaluation. Manufacturers must align technical documentation and conformity assessments with these revised standards to maintain market access and ensure regulatory compliance.

1 Apr 2026, 19:02eur-lex.europa.euEuropean UnionEuropean Economic Area

China NMPA Issues 103rd Batch of Reference Preparations for Generic Drugs (Notice 8/2026)

China's NMPA issued the 103rd batch of generic-drug reference preparations in March 2026, adding new substances and updating marketing authorization holder (MAH) data. Developers must align bioequivalence studies and dossier submissions with these updated comparators to maintain compliance and secure market approvals for generic products.

1 Apr 2026, 18:39nmpa.gov.cnChina

South Korea MFDS Consults On Draft Partial Amendment to Medical Device Approval, Notification and Examination Regulation (Notice No. 2026-167)

South Korea's MFDS proposed amendments to medical device regulations on March 30, 2026, to streamline approval processes and transition periods. The changes facilitate market access by expanding the use of real-world evidence and reducing administrative burdens for foreign-language documentation and product modifications.

1 Apr 2026, 18:39mfds.go.krSouth Korea

US House Introduces FAIR Act (H.R. 7953) on Reciprocal Rare Disease Drug Approvals

The US House introduced the FAIR Act (H.R. 7953) to establish reciprocal marketing approval pathways for rare disease therapies authorized by trusted foreign regulators. This proposal signals a shift toward international regulatory harmonization, potentially accelerating US market entry for innovative drugs and biologics.

1 Apr 2026, 14:17govinfo.govUnited States

US FDA Grants Accelerated Approval To Kresladi Gene Therapy For Severe LAD-I

The US FDA has granted accelerated approval to Kresladi, the first gene therapy for severe Leukocyte Adhesion Deficiency Type I (LAD-I). This decision confirms the viability of biomarker-based approval pathways for gene therapies, provided manufacturers commit to rigorous post-market clinical validation.

28 Mar 2026, 20:29fda.govUnited States

US House Bill Proposes National Institute for Biomedical Research and Development (H.R. 7854)

US House Bill H.R. 7854 proposes a $90 billion National Institute for Biomedical Research and Development to conduct full-cycle drug and device R&D with federal ownership of all resulting intellectual property. If enacted, this would fundamentally disrupt the private life sciences sector by mandating public data sharing, cost-plus licensing, and potential government-led manufacturing.

28 Mar 2026, 09:34govinfo.govUnited States

EU Council Circulates Final Compromise Text for New Medicinal Products and EMA Regulation

The EU Council has finalized the compromise text for the new Pharmaceutical Regulation, consolidating the authorization and supervision framework for human medicines and advanced therapies. Marketing authorization holders must adapt to more stringent supply chain transparency requirements, mandatory shortage prevention plans, and a recalibrated system of market exclusivity incentives.

27 Mar 2026, 20:54data.consilium.europa.euEuropean Union

US FDA Publishes FY 2025 GDUFA Science and Research Report on Generic Drug Priorities

The US FDA has released its FY 2025 GDUFA Science and Research Report, detailing over 50 projects aimed at accelerating the development and assessment of complex generic drugs. Generic drug sponsors should align their analytical methods and bioequivalence study designs with the FDA's prioritized focus on nitrosamine impurities, complex active ingredients, and the integration of AI/ML tools.

27 Mar 2026, 20:22fda.govUnited States

ANVISA Introduces New Subject Code for Bioequivalence Study Petitions

ANVISA has introduced a new subject code (12413) to standardize petitions for modifying the official list of analytes and administration forms in bioequivalence studies. Companies must adopt this procedural update to streamline regulatory submissions and prevent delays in drug registration and clinical trial approvals in Brazil.

26 Mar 2026, 19:29gov.brBrazil

UK MHRA Sets Out Approach To Medicines Using Non-Animal Methods

The UK MHRA has introduced a formal framework and a 2026 pre-review mechanism to facilitate the use of non-animal testing methods (NAMs) in medicines regulation. This provides a clear pathway for developers to de-risk animal-free evidence packages, signaling a long-term regulatory pivot that prioritizes scientific justification over traditional animal-based testing protocols.

26 Mar 2026, 19:23gov.ukUnited Kingdom

Georgia SB 631 Would Fund FDA-Approved Ibogaine Clinical Trials for Veterans

Georgia SB 631 proposes state-funded grants for FDA-approved clinical trials using ibogaine to treat veterans' mental health and substance use disorders. This initiative reflects growing state-level momentum to support psychedelic research, potentially paving the way for future therapeutic approvals and specialized pharmaceutical market opportunities.

26 Mar 2026, 19:18legis.ga.govUnited States

Minnesota HF4577 Would Establish Psilocybin Therapeutic Use Program and Reschedule Psilocybin

Minnesota has introduced HF4577 to create a regulated psilocybin therapeutic program and reschedule the substance to Schedule IV. The proposal establishes a state-level framework for a controlled psychedelic market, mandating strict standards for cultivation, testing, and clinical administration.

26 Mar 2026, 19:06revisor.mn.govUnited States

France / ANMV Issues February 2026 Veterinary Medicinal Product Decisions and Highlights Duck Vaccination and VICH GL9 Activities

France’s ANMV has issued its February 2026 veterinary medicinal product decisions and updated its strategy for mandatory avian influenza vaccination and clinical trial harmonization. Stakeholders must assess specific marketing authorization modifications and prepare for increased European alignment in clinical trial inspections under the VICH GL9 framework.

26 Mar 2026, 11:42anses.frFranceEuropean Union

EU Commission Adopts Delegated Regulation C(2026)1798 Expanding MDR Clinical-Investigation Exemptions for Implantable and Class III Devices

The EU Commission has adopted a Delegated Regulation expanding the list of implantable and Class III medical devices exempted from mandatory clinical investigations under the MDR. This expansion for "well-established technologies" streamlines market access and reduces clinical data burdens for mature product lines while maintaining rigorous clinical evaluation standards.

24 Mar 2026, 09:54eur-lex.europa.euEuropean Union

California AB 2442 Proposes Investigational Peptide and Novel Compound Research and Therapeutic Access Program

California's AB 2442 proposes a state-sanctioned framework for research and therapeutic access to investigational peptides, mandating strict adherence to cGMP and supply chain standards. This creates a regulated pathway for non-FDA-patented compounds, requiring manufacturers and healthcare entities to align with rigorous quality control and reporting protocols.

23 Mar 2026, 14:45leginfo.legislature.ca.govUnited States

Philippines FDA Consults On Content Of License To Operate (LTO) For Pharmaceutical Establishments

The Philippines FDA has proposed standardized License to Operate (LTO) templates for pharmaceutical establishments, with a consultation period closing April 24, 2026. This shift to a uniform format and mandatory re-issuance for operational changes requires firms to update internal compliance tracking to ensure uninterrupted market access.

20 Mar 2026, 12:44fda.gov.phPhilippines

Belgium Notifies Draft Royal Decree on Distribution Authorisations for Clinical Trial Medicinal Products (TRIS 2026/0134/BE)

Belgium has notified a draft decree requiring specific authorizations for the distribution of investigational and ancillary medicinal products used in clinical trials. Companies managing clinical supply chains must prepare for enhanced oversight and ensure Belgian-based or EU-wide distributors meet new procedural and compliance standards.

19 Mar 2026, 12:51technical-regulation-information-system.ec.europa.euBelgiumEuropean Union