OTC Medicines

Taiwan MOHW Proposes Rules for OTC Drug Package Inserts and Outer Box Labelling

In May 2026 Taiwan’s Ministry of Health and Welfare, via TFDA, issued a draft rule to standardise package-insert and outer box labelling (including QR codes) for non-prescription (OTC) Western medicines and opened a 60-day public consultation. If adopted, companies marketing OTC drugs in Taiwan will need to update artwork, QR codes and information content to match the new templates and prepare for a proposed 1 July 2027 shift to fully electronic package inserts.

13 May 2026, 11:57fda.gov.twTaiwan

Iowa Legislature Passes HF2676 to Restrict Food Additives in School Meals and Allow OTC Ivermectin

The Iowa legislature has passed HF2676, a multifaceted health bill that would ban several synthetic food dyes, potassium bromate, and propyl paraben from school meals from the 2027–28 school year while allowing pharmacies to dispense ivermectin over the counter. If enacted, food manufacturers supplying Iowa schools and retail pharmacies in the state will need to plan for product reformulation, procurement shifts, and updated risk and communications policies ahead of the new school-year compliance date.

24 Apr 2026, 08:57legis.iowa.govUnited States

China NMPA Issues Pregabalin Management Notice and Reclassifies Ophthalmic Eye Drops to OTC

China’s drug regulator and public security authorities have issued a joint notice to further strengthen management of pregabalin and other medicines, while also releasing a new batch of generic-drug reference preparations and converting key ophthalmic solutions from prescription-only to OTC status in April 2026. These moves signal closer control of potentially abuse-prone medicines and expanded OTC and generic channels, so pharmaceutical marketing and regulatory teams should review the Chinese notices quickly to update labelling, plan lifecycle strategy, and manage supply and compliance risks in the China market.

24 Apr 2026, 08:45nmpa.gov.cnChina

China NMPA Converts Compound Sodium Chloride Eye Drops From Prescription To OTC

China’s National Medical Products Administration has reclassified compound sodium chloride eye drops from prescription-only to over-the-counter status (Announcement No. 36 of 2026), with marketing authorisation holders required to update documentation by early 2027. This widens OTC access in China’s eye-care market but immediately triggers leaflet and labelling revisions, provincial filings, and portfolio checks for any products containing this preparation.

23 Apr 2026, 09:31nmpa.gov.cnChina

China NMPA Converts Azelastine Hydrochloride Eye Drops From Prescription To OTC (Announcement No. 37/2026)

In April 2026, China’s National Medical Products Administration converted azelastine hydrochloride eye drops (盐酸氮䓬斯汀滴眼液) from prescription-only to over-the-counter status through Announcement No. 37/2026, publishing the affected product list and an OTC leaflet template. Marketing authorisation holders now have until early 2027 to update inserts and labelling and inform healthcare and distribution partners, creating new OTC market opportunities but requiring prompt packaging, regulatory, and supply-chain adjustments.

21 Apr 2026, 13:57nmpa.gov.cnChina

US FDA Updates FY 2026 OMUFA Fees and Facility Status Lists

FDA has updated its OMUFA programme page with FY 2026 facility and OMOR fee rates, a 1 June 2026 facility fee due date, and refreshed arrears and paid facility lists that show which OTC monograph drug facilities have paid their FY 2025 user fees. OTC monograph sponsors and contract manufacturers should verify their facility’s FEI entry on the new lists, plan for the revised FY 2026 fee levels, and ensure timely electronic payment to avoid appearing in arrears or risking future disruption to monograph operations.

18 Apr 2026, 08:09fda.govUnited States

US FDA Publishes Lists of Companies That Did Not Submit 2024 Drug Amount Reports

The US FDA has publicly identified drug registrants that failed to submit mandatory 2024 annual production volume reports, signaling a shift toward more transparent enforcement. Impacted companies face immediate reputational exposure and must urgently rectify reporting gaps to avoid further regulatory scrutiny and ensure continued market access.

2 Apr 2026, 17:37fda.govUnited States

US House Introduces HERO Act (H.R. 7994) on Opioid Overdose Reversal Drugs in Schools

The US House introduced the HERO Act to establish federal grants for school-based opioid overdose reversal drugs and emergency response training. Organizations should anticipate increased procurement demand and new mandatory reporting requirements for drug distribution into national surveillance systems.

2 Apr 2026, 11:07govinfo.govUnited States

Brazil (ANVISA) Prohibits Irregular Dermatological Medicines and Esthetic Products Sold Online

Brazil’s health regulator prohibited the sale and advertising of unregistered dermatological medicines and aesthetic medical devices via e-commerce platforms in March 2026. This enforcement action signals intensified scrutiny of digital supply chains and underscores the necessity for rigorous verification of sanitary registrations and authorized distributors in the Brazilian market.

29 Mar 2026, 19:12gov.brBrazil

Australia TGA Opens Consultation On Improving Sunscreen Regulation

Australia has initiated a comprehensive consultation to modernize sunscreen regulations, focusing on SPF testing reliability, laboratory oversight, and ingredient standards. Businesses should anticipate stricter quality assurance mandates, updated manufacturing guidelines, and harmonized labeling requirements across therapeutic and cosmetic categories.

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

Netherlands Water Boards Ask CBG To Act On Environmentally Harmful Self-Care Medicines

Dutch water authorities are formally requesting the medicines regulator to restrict over-the-counter sales of environmentally harmful topical analgesics like diclofenac. This signals a shift toward integrating environmental impact into pharmaceutical market access, potentially leading to stricter labeling or prescription-only status for high-risk substances.

28 Mar 2026, 17:10unievanwaterschappen.nlNetherlands

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 across tested pharmaceuticals with only one specific dissolution failure identified. This update signals the agency's continued reliance on risk-based post-market testing to drive enforcement, necessitating rigorous quality control and supply chain oversight for manufacturers.

27 Mar 2026, 20:09fda.govUnited States

EU Council Circulates Draft Directive on Union Code for Medicinal Products for Human Use (Repeal of Directives 2001/83/EC and 2009/35/EC)

The EU Council is advancing a comprehensive proposal to consolidate the regulatory framework for human medicinal products into a single Union Code. This legislative overhaul will fundamentally reshape market access and supply chain obligations, requiring a strategic reassessment of pharmaceutical portfolios and long-term compliance strategies.

27 Mar 2026, 19:54eur-lex.europa.euEuropean Union

Netherlands Council Of State Refers Food Supplement–Medicine And Online Review Questions To CJEU (ECLI:NL:RVS:2026:1651)

The Dutch Council of State has referred questions to the CJEU to define the legal boundary between food supplements and medicinal products in online retail. This ruling will determine if consumer reviews and digital presentation can trigger pharmaceutical-level liability, reshaping compliance and moderation risks for health product platforms.

27 Mar 2026, 08:25uitspraken.rechtspraak.nlNetherlandsEuropean Union

Brazil Enacts Law Allowing Pharmacies And Drugstores In Supermarkets

Brazil enacted Law No. 15.357/2026 in March 2026, permitting pharmacies to operate within supermarket premises under strict sanitary and operational conditions. This shift expands retail competition and market access while requiring rigorous compliance with physical segregation, pharmacist oversight, and controlled substance handling.

26 Mar 2026, 11:59normas.leg.brBrazil

US FDA Issues Drug Safety Communication on Accidental Ingestion of OTC Eye Drops and Nasal Sprays by Children

The FDA re-issued a safety warning in March 2026 regarding life-threatening pediatric risks from accidental ingestion of OTC eye drops and nasal sprays containing specific active ingredients. Businesses should anticipate mandatory child-resistant packaging requirements and stricter labeling standards as regulatory scrutiny of consumer product safety intensifies.

26 Mar 2026, 11:29fda.govUnited States

US FDA Announces Cardinal Health Recall of Webcol Large Alcohol Prep Pads for Microbial Contamination

Cardinal Health initiated a voluntary consumer-level recall of alcohol prep pads in March 2026 following the detection of microbial contamination. This action emphasizes the increasing scrutiny on sterile manufacturing standards and the necessity for agile recall management to protect patient safety and brand reputation.

24 Mar 2026, 11:22fda.govUnited StatesPuerto RicoJapan

US House Introduces H.R. 7980 To Expand FFDCA Drug Recall Authority

Proposed US legislation seeks to expand the FDA's mandatory recall authority to cover all drug categories beyond currently restricted controlled substances. This shift would significantly elevate compliance risk and operational liability for pharmaceutical manufacturers by granting the regulator broader powers to remove products from the market.

21 Mar 2026, 09:05congress.govUnited States

US FDA Issues Draft Guidance On New Approach Methodologies In Drug Development

The US FDA has proposed a validation framework for New Approach Methodologies to serve as alternatives to animal testing in drug and OTC monograph development. This shift toward human-biology-based testing offers a pathway to reduce animal data reliance but requires rigorous, fit-for-purpose validation to meet regulatory standards.

20 Mar 2026, 13:47public-inspection.federalregister.govUnited States

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

The Philippines FDA has proposed standardized License to Operate templates for pharmaceutical establishments, with a consultation period closing April 24, 2026. This shift toward uniform technical documentation and mandatory re-issuance for operational changes requires firms to align internal compliance tracking with new mandatory disclosure formats.

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