Clinical Trials

US FDA Seeks Comment on Draft and Revised Product-Specific Bioequivalence Guidances for Multiple Drug Products

In May 2026 the US Food and Drug Administration announced a new wave of draft and revised product-specific bioequivalence guidances for numerous generic drug products and opened a 60-day public comment period ending 21 July 2026. Generic developers should review which active ingredients are covered, align their current or planned ANDA bioequivalence study designs with FDA’s latest expectations, and decide where to submit comments before the guidances are finalised.

23 May 2026, 19:27federalregister.govUnited States

China NMPA Applies ICH M13A Bioequivalence Guideline to Oral Immediate‑Release Solid Dosage Forms (Announcement No.49, 2026)

China’s National Medical Products Administration has decided that, from 20 May 2026, all new registration applications for oral immediate-release solid drugs must base their bioequivalence studies on the ICH M13A guideline, with a one-year transition for studies already initiated under previous protocols. This move aligns China’s generic-drug bioequivalence requirements with international practice, tightening expectations for trial design and analysis and signalling more predictable, globally harmonised review standards for sponsors targeting the Chinese market.

23 May 2026, 08:56nmpa.gov.cnChina

China NMPA Applies ICH M13A Bioequivalence Guideline for Oral Immediate-Release Solid Dosage Forms (Announcement No. 49, 2026)

China’s National Medical Products Administration has applied the ICH M13A bioequivalence guideline to all new registration applications for oral immediate-release solid dosage forms, effective 20 May 2026. Companies developing or registering oral solid drugs in China must align bioequivalence study design and analysis with this global standard, using a one-year transition window for ongoing studies, which may affect trial planning, dossiers, and time-to-market strategies.

23 May 2026, 08:55nmpa.gov.cnChina

EMA, EC and HMA Publish First ACT EU Quarterly Clinical Trial KPI Report (January–March 2026)

EU regulators have issued the first ACT EU quarterly report tracking progress towards 2030 targets to increase multinational clinical trials and speed up trial start‑up, using Q1 2026 CTIS data as the initial benchmark. The KPIs show early but incomplete progress (19 extra multinational trials and about 40% of trials recruiting within 200 days versus a 66% 2030 goal), signalling sustained EU focus on faster, more attractive clinical trial pathways rather than immediate new legal obligations.

22 May 2026, 16:44accelerating-clinical-trials.europa.euEuropean Union

EMA Lists Medicines for 2026 Product-Specific Bioequivalence Guidance

In May 2026 the European Medicines Agency signalled its 2026 pipeline of product-specific bioequivalence guidelines for fourteen active substances, including several high-profile small molecules and GLP-1 analogues. This flags upcoming detailed expectations for bioequivalence study design in EU generic and hybrid applications, giving developers time to plan protocols and portfolios around the forthcoming guidance.

21 May 2026, 15:52ema.europa.euEuropean Union

EU Parliament Refers European Biotech Act Proposal to SANT and ITRE Committees

In May 2026, the European Parliament formally received the Commission’s European Biotech Act proposal and assigned it jointly to its health (SANT) and industry (ITRE) committees, opening the parliamentary phase of the file. This referral signals that wide-ranging changes to EU rules on biotechnology, clinical trials, and food and veterinary law are now moving into political negotiation, so companies should monitor the process for future procedural and compliance impacts even though no new obligations arise at this stage.

21 May 2026, 15:51eur-lex.europa.euEuropean Union

Hong Kong Announces Drug And Medical Device Regulatory Reforms And New Medical Products Regulator

Hong Kong’s Chief Executive has announced major reforms to drug and medical device oversight, including a “1+” registration pathway, phased primary evaluation starting in March 2026, and a new medical products regulator to be established by the end of 2026 on the way to a fully independent evaluation framework by 2030. These changes point to faster, more autonomous approval decisions and greater use of cross-boundary clinical and real-world data, so pharma and medtech companies should plan for a distinct Hong Kong regulatory regime when allocating trials, submissions, and investment over the rest of the decade.

20 May 2026, 17:57news.gov.hkHong Kong SAR ChinaChina

Brazil (Anvisa) Suspends Corticosteroid and Cholesterol Medicines and Publishes 2nd GCP Inspection Metrics Report

In May 2026, Brazil’s Anvisa suspended specific dexamethasone and statin medicine batches, seized multiple unregistered herbal products, and published a second metrics report on Good Clinical Practice inspections for 2024–2025. These actions reinforce immediate product-safety obligations for affected medicines and signal ongoing tightening of clinical-research oversight under Brazil’s new human-research law, raising expectations for sponsors, CROs, and study sites operating in the country.

20 May 2026, 17:52gov.brBrazil

China NMPA Publishes Policy Interpretation on Measures for the Protection of Drug Trial Data

China’s National Medical Products Administration has issued a policy interpretation article and infographic explaining the new Measures for the Protection of Drug Trial Data, adding official guidance on how the data-protection regime will be applied in practice. This signals that pharmaceutical sponsors and marketing authorisation holders should reassess how the measures affect their pipelines and pending applications, and align internal processes and documentation with NMPA’s expectations on trial data protection.

19 May 2026, 21:31nmpa.gov.cnChina

China NMPA Issues Implementation Measures for Drug Trial Data Protection (2026 Announcement No. 47)

China’s National Medical Products Administration has issued binding Implementation Measures for drug trial data protection, effective immediately on 15 May 2026, and set transition rules for pending marketing authorisation applications. The new regime tightens control over how clinical trial data can be relied on, forcing originators to apply quickly for protection and temporarily blocking follow‑on applications, which will influence exclusivity strategies and generic entry planning in the Chinese pharmaceutical market.

19 May 2026, 15:28nmpa.gov.cnChina

China NMPA Publishes Implementation Measures for Drug Trial Data Protection (Announcement No. 47 of 2026)

On 15 May 2026, China’s National Medical Products Administration published binding Implementation Measures for drug trial data protection through Announcement No. 47 of 2026, effective immediately. The measures create a formal application process and tight 15-day windows for existing drug registration dossiers, and temporarily block new applications that would rely on protected trial data, so companies must quickly assess which products need protection requests and adjust China filing strategies accordingly.

18 May 2026, 17:54nmpa.gov.cnChina

China NMPA Issues Measures for Protection of Drug Trial Data

China’s National Medical Products Administration has issued implementing Measures for the Protection of Drug Trial Data, effective from 15 May 2026, together with an announcement setting short transitional rules for pending registration applications. This creates a formal data protection regime for qualifying clinical trial data, so originator companies must quickly decide whether to seek protection while generic and follow‑on applicants reassess filing strategies around the new exclusivity and timing constraints.

18 May 2026, 17:47finance.sina.cnChina

US FDA Lists Ongoing Accelerated Approvals for Infectious Disease Vaccines

In May 2026 the US FDA refreshed its public listing of vaccines that hold accelerated approval for infectious-disease indications, detailing the associated confirmatory postmarketing trials and projected completion dates for each product. These timelines indicate when key efficacy evidence could trigger conversion to full approval or regulatory action, helping manufacturers and healthcare stakeholders assess portfolio risk and plan for potential labelling or market-access changes.

18 May 2026, 17:30fda.govUnited States

California AB 2442 (Peptides) Held Under Submission by Assembly Appropriations Committee

On 14 May 2026, the California Assembly Appropriations Committee held AB 2442 (Peptides) under submission, stalling a bill that would create a state working group on investigational peptide and novel compound frameworks. This eases immediate compliance pressure for peptide manufacturers and clinicians in California, but the mandated study and 2029 report signal sustained policy attention that could shape future, more prescriptive legislation.

16 May 2026, 14:46leginfo.legislature.ca.govUnited States

Colorado General Assembly Passes HB26-1325 on Ibogaine Research and Natural Medicine Licensing

In May 2026 the Colorado General Assembly passed HB26-1325, expanding the state’s natural medicine framework to cover ibogaine, creating a conditional ibogaine research pilot program, and tightening licensing, benefit-sharing and advertising rules for natural medicine businesses, with an effective date in August 2026 subject to referendum and funding triggers. These changes signal a more formalised, research-driven and compliance-heavy environment for psychedelic and natural medicine services in Colorado, affecting how ibogaine can be supplied and administered, how healing centres structure sales and licences, and how harm reduction and support services can be marketed and documented.

15 May 2026, 13:34leg.colorado.govUnited States

China CDE Publishes 2025 Annual Drug Evaluation Report

China’s Center for Drug Evaluation has published its 2025 Annual Drug Evaluation Report, detailing last year’s growth in drug registration activity, innovative and rare disease approvals, and extensive use of accelerated review pathways. The report signals continued prioritisation of clinically valuable innovation, expanded technical guidance and ICH alignment, and further digitalisation and reform of China’s drug review system in 2026, shaping expectations for sponsors’ development and submission strategies.

15 May 2026, 13:31cde.org.cnChina

China NMPA Issues 105th Batch of Generic Drug Reference Preparations Directory (Notice No. 17 of 2026)

China’s National Medical Products Administration has issued Notice No. 17 of 2026 to publish the 105th batch of its Catalogue of Reference Preparations for Generic Drugs, with an attached directory of reference products used in quality and efficacy consistency evaluations. Generic drug developers should review the updated list to see whether their products are affected and align upcoming bioequivalence and consistency studies and related submissions with the latest NMPA reference preparations.

15 May 2026, 13:27nmpa.gov.cnChina

US FDA Final Guidance on Developing Drugs for Clostridioides Difficile Infection

In May 2026 FDA issued final guidance for industry on developing drugs to treat, reduce recurrence of, and prevent Clostridioides difficile infection, replacing its 2022 draft. This clarifies FDA’s current expectations for CDI drug development programmes, shaping trial design and regulatory strategy for sponsors planning new or modified indications.

15 May 2026, 09:32fda.govUnited States

US FDA Draft Guidance on Development of Non-Opioid Analgesics for Chronic Pain

In September 2025 the US FDA issued draft guidance outlining its expectations for phase 3 development of non-opioid analgesic drugs to treat chronic pain. Although the comment period closed in November 2025, sponsors planning chronic pain programmes should align trial designs with this framework and monitor for the final guidance, as it will shape US market access expectations for non-opioid analgesics.

15 May 2026, 09:11fda.govUnited States

EMA Restricts Mpox Indication for Tecovirimat SIGA

EMA has restricted the indication for Tecovirimat SIGA so that new patients should not start the medicine for mpox after randomised trials showed no efficacy versus placebo. Use is now limited to smallpox, cowpox and vaccinia-related complications, meaning clinicians and health systems must adjust mpox treatment pathways and reconsider reliance on tecovirimat in outbreak planning.

15 May 2026, 09:02ema.europa.euEuropean UnionNorway