Policies & Legislation
China's 12th VBP round accelerates shift to generics and biosimilars dual-track
China’s government has initiated enterprise submissions for its 12th national Volume-Based Procurement (VBP) batch, signalling an intensive new phase in its campaign to restructure healthcare costs. Run by the National Healthcare Security Administration (NHSA), this June 2026 procurement round places an estimated RMB 60 billion (US$8.8 billion) market up for grab across 65 critical drug varieties, aggressively accelerating the mandatory substitution of off-patent originators with low-cost generics and biosimilars.
House Bill aims to crack down on China biotech deals
A bipartisan House bill proposed on 2 June 2026 would require government screening of US investments in Chinese biotechnology, following two pharmaceutical deals potentially worth more than US$10 billion each.
Costa Rica opens consultation on biological medicines registration and control reform
The Costa Rican Ministry of Health has initiated a 60-day public consultation period on proposed amendments to Executive Decree No. 37006-S of 15 November 2011 [1, 2], which establishes the regulatory framework for the registration and control of biological medicines under ‘RTRC 440: 2010’ (Reglamento de Inscripción y Control de Medicamentos Biológicos).
China updates regulations to encourage research and innovation and improved drug safety
On 31 December 2025, China’s State Council announced a revision of Regulation for the Implementation of the Drug Administration Law, which is expected to encourage research and innovation in the country. This revision aims to strengthen the legal foundation for ensuring high-level drug safety and supporting the high-quality development of the nation’s pharmaceutical industry.
Brazil and Mexico forge alliance to streamline medical approvals and boost production
Brazil and Mexico have forged a dual regulatory and production alliance to streamline medical product approvals and boost regional manufacturing capacity for critical health technologies.
EU accepts results from FDA GMP inspections for sites outside the US
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
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
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
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
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.
