Policies & Legislation

EU accepts results from FDA GMP inspections for sites outside the US

Home/Policies & Legislation | Posted 27/01/2026

On 1 October 2025, the European Medicines Agency (EMA) announced a significant enhancement to the existing Mutual Recognition Agreement (MRA) with the US Food and Drug Administration (FDA). As a result, EU regulators will be able to voluntarily rely on FDA inspections of manufacturing sites outside the US when assessing human-medicinal-product applications and relevant variations [1].

WHO to remove animal tests and establish 17 reference standards for biologicals

Home/Policies & Legislation | Posted 07/01/2026

October 2025 saw the 81st meeting of the World Health Organization (WHO) Expert Committee on Biological Standardization (ECBS) held from 13 to 16 October in Tunis, Tunisa (and virtually) [1].

New direction for health regulation in Mexico

Home/Policies & Legislation | Posted 05/12/2025

Mexico's health regulator, Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS, has embarked on a profound modernization to drastically cut approval times, aiming to become a globally recognized benchmark for efficiency and innovation.

Argentina streamlines drug approval process

Home/Policies & Legislation | Posted 13/11/2025

Argentina's National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT) has streamlined drug approvals, reducing review times to accelerate market access for new medicines while upholding safety and quality standards.

ANVISA tackles 24-month backlog in biologicals post-registration petitions

Home/Policies & Legislation | Posted 10/10/2025

In a bid to accelerate the review of post-approval changes for biological products, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) has launched an enhanced phase of its Optimized Online Analysis Project. Managed by the Biological Products Evaluation Team (GPBIO), the initiative targets a significant reduction in the current 24-month backlog for post-registration petitions.

US EO: delivering Most-Favored-Nation Prescription Drug Pricing to American patients

Home/Policies & Legislation | Posted 03/10/2025

A new Trump Executive Order seeks to slash US prescription drug prices by mandating they match the lowest costs in comparable OECD countries, a significant policy shift facing legal and industry challenges.

Uruguay to establish independent AUVISA drug agency for healthcare reform

Home/Policies & Legislation | Posted 17/09/2025

Uruguay is taking a crucial step toward enhancing its healthcare system by establishing its first independent regulatory agency for medicines and medical devices. This initiative, aimed at streamlining the approval and supervision of drugs, seeks to make treatments more accessible and affordable for the entire population.

Malaysia announces Screening Package for new drugs and biologicals

Home/Policies & Legislation | Posted 25/08/2025

To enhance the submission process for new drugs and biological products, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has developed a dedicated a dedicated Screening Package. This initiative aims to provide clearer guidance and promote Good Submission Practice by helping applicants ensure their dossiers are complete and meet regulatory requirements before submission.

Trump’s ‘One Big Beautiful Bill’: implications for US health care

Home/Policies & Legislation | Posted 14/08/2025

On 4 July 2025, US President Donald Trump signed into law a tax and spending package designed to fulfil several of his electoral campaign promises. These relate to tax cuts, immigration enforcement and more. However, it may have serious implications for health care, with potentially significant cuts to Medicaid.

DIGEMID’s 45-day auto-approvals trigger safety warning

Home/Policies & Legislation | Posted 30/06/2025

Peru’s new regulation allows automatic drug approval if DIGEMID (DIGEMID (General Directorate of Medicines, Supplies, and Drugs, Dirección General de Medicamentos, Insumos y Drogas) does not respond within 45 days, raising concerns about compromised safety controls. Critics warn it may permit substandard medicines, especially biologicals and biosimilars, without proper evaluation, endangering public health. Stakeholders urge revisions.

ANVISA and Danish Medicines Agency renew health regulatory collaboration

Home/Policies & Legislation | Posted 06/05/2025

ANVISA, Brazil’s Health Regulatory Agency, and the Danish Medicines Agency (DKMA) have renewed their collaboration for another three years (April 2025–March 2028). This partnership, established in 2016, aims to enhance public health and regulatory practices through knowledge exchange and joint initiatives.

Colombia and Brazil introduce reforms to enhance healthcare regulation

Home/Policies & Legislation | Posted 22/04/2025

Colombia and Brazil have introduced reforms aimed at improving efficiency and transparency in their health sectors, marking a significant step forward toward enhancing healthcare regulation and accelerating access to medical products and clinical trials.

Second wave of drugs selected for Medicare price negotiation

Home/Policies & Legislation | Posted 11/04/2025

In January 2025, the US Department for Health and Human Security (HHS) announced the addition of 15 more Medicare Part D drugs selected for price negotiations.

NPRA Malaysia trials new timelines for variation applications

Home/Policies & Legislation | Posted 05/11/2024

In May 2024, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) announced that it will trial new timelines for variation applications of registered pharmaceutical products and natural health supplements (TMHS).

Regulatory evolution and impact of simplified requirements for interchangeable biosimilars in the US

Home/Policies & Legislation | Posted 18/09/2024

This article examines the evolving regulatory landscape for simplified requirements for interchangeable biosimilars in the US. It explores recent US Food and Drug Administration (FDA) approvals, the role of switching studies, and updated labelling guidance, highlighting key changes and their implications for biosimilar development and use.

China’s NMPA expands global ties with the Netherlands and Indonesia

Home/Policies & Legislation | Posted 04/09/2024

China’s National Medical Products Administration (NMPA) has met with leaders from the Netherlands and Indonesia to discuss potential collaborations with these countries.

Japan's PMDA expands influence with new office in Thailand

Home/Policies & Legislation | Posted 06/08/2024

On 1 July 2024, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) announced the establishment of its first overseas office, the PMDA Asia office. This office is now open in Bangkok, Thailand, and is headed by Dr Kitahara Jun.

Panama embraces international pharmacovigilance standards

Home/Policies & Legislation | Posted 09/07/2024

Panama is implementing internationally standardized reporting codes for pharmacovigilance by adopting WHODrug Global and MedDRA dictionaries, following the example of several other Latin American and Caribbean countries.

FDA proposal to remove biosimilar interchangeability status in FY25

Home/Policies & Legislation | Posted 12/06/2024

In a major shift in regulatory policy, the US Food and Drug Administration (FDA) is calling on Congress to remove the interchangeability designation that has historically set biosimilars apart in the US market. Backed by the Biden administration, the FDA's new proposal would permit pharmacy-level substitution of biosimilar drugs for reference products without clinician recommendation. This would extend to all approved biosimilars, regardless of their interchangeability status.

MHRA unveils strategy for regulating AI technologies

Home/Policies & Legislation | Posted 22/05/2024

In April 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a policy paper on its strategic approach to artificial intelligence (AI) [1]. It summarises the MHRA’s view on the UK government’s white paper on AI regulation published in 2023 [2] and is the agency’s response to the Secretary of State letter of 1 February 2024 [3].

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