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Policies & Legislation

Pharmacovigilance V13F21

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.

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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.

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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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Regulatory Certainty Strategy for biosimilars launched in Mexico

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

In February 2024, Mexico’s COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) announced the ‘Estrategia de Certidumbre Regulatoria’ – Regulatory Certainty Strategy (RCS) – for biosimilars.

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Strategic plans of ANVISA and COFEPRIS to advance health regulation

Home/Policies & Legislation | Posted 11/03/2024

ANVISA and COFEPRIS, Brazilian and Mexican health regulatory agencies respectively, unveil strategic plans for 2024-2027. ANVISA prioritizes World Health Organization (WHO) recognition, identification of medicinal products (IDMP) standards adoption, and biosimilar drug development. COFEPRIS focuses on regulatory certainty, digitalization, and aligning with global manufacturing standards.

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Panama enacts new bill to guarantees the supply of medicines

Home/Policies & Legislation | Posted 29/02/2024

On 18 January 2024, the National Assembly (AN-Panamanian Parliament) approved in the third debate Bill 1007, which regulates medicines, supplies, devices, and other products for human health, their public acquisition, and other provisions were enacted.

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EMA concept paper towards a tailored clinical approach in biosimilar development

Home/Policies & Legislation | Posted 09/02/2024

In November 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) published a 'Concept paper for the development of a reflection paper on a tailored clinical approach in biosimilar development'. 

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Public consultation for the modification of the biosimilars regulation in Brazil

Home/Policies & Legislation | Posted 16/01/2024

The Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA) initiated a public consultation on expediting regulation of biosimilar drugs. The goal is to decrease dependence on high-cost imported biological medicines and position Brazil as a significant regional exporter of lower-cost biological therapies.

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COFEPRIS promotes regulatory cooperation in the Americas

Home/Policies & Legislation | Posted 12/12/2023

During the 60th Executive Council of the Pan American Health Organization (PAHO) held in Washington, DC, USA, on 25–28 September 2023, Alejandro Svarch Pérez, Head of the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), on behalf of the Mexican government, emphasized the need to strengthen healthcare systems based on primary care.

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CMS proposes allowing Part D plans to switch biologicals to non-interchangeable biosimilars

Home/Policies & Legislation | Posted 21/11/2023

On 6 November 2023, the U.S. Centers for Medicare & Medicaid Services (CMS) proposed a new rule to give Medicare Part D plans more flexibility. It has been proposed that biosimilars can now be substituted for the reference biologicals, even if these have not been deemed interchangeable by the US Food and Drug Administration (FDA).