On 31 May 2021, COFEPRIS published the Decree which specifies changes to the Health Supplies Regulation (Reglamento de Insumos para la Salud, RIS). These changes, most of which are effective immediately, streamline administrative processes, focus on health surveillance, and promote openness and innovation in global health inputs.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on biosimilars, softening the rules in order to enable these products to reach the UK market faster.
The decree on the 'Regulation for the Prescription of Medicines in Conformity with their International Nonproprietary Name (INN) for the Costa Rican private market' has been promoted by the Ministry of Health since 2018 and establishes that all doctors, dentists and obstetricians are obliged to prescribe medicines by their international non-proprietary name or generic name and not by brand name. The regulation also adds that doctors will be able to include the brand name of the medicine in the prescription if there are 'clinico-pharmacological reasons' that justify recommending that product.
The National Institute for Health and Care Excellence (NICE), which publishes clinical guidance for England, has recommended the use of new biological drugs for the treatment of moderate rheumatoid arthritis. The treatments have become available thanks to biosimilars, which have drastically reduced costs to the National Health Service (NHS) in England.
On 31 May 2021, the Mexican President published on the Federal Official Gazette a major amendment to the Secondary Regulations for Health Supplies (Reglamento de Insumos para la Salud, ‘RIS’) (‘Decree’).
On 10 January 2021, the Peruvian Ministry of Health (Ministerio de Salud del Perú, MINSA), which is in charge of leading the National and Decentralised Health System, the policy for the universal health assurance and the policies and intersectoral actions on social determinants, published in the Official Gazette Diario Oficial El Peruano the supreme decree 002-2021-SA that approves the regulation for the Conditional Health Registration of Medicines and Biological Products.
The US Food and Drug Administration (FDA) has published final guidance on ‘M9 Biopharmaceutics Classification System (BCS)-Based Biowaivers’. The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
The US Food and Drug Administration (FDA) has released guidance on generic drug development and the submission of abbreviated new drug applications (ANDAs) during COVID-19, which explains how manufacturers can overcome issues caused by the pandemic.
In the wake of Brexit, which took effect on 1 January 2021, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new biosimilars pathway for the UK.
The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) announced on 30 December 2020 that it had published new guidelines for the pricing and reimbursement of medicines, which include a new streamlined procedure for generics and biosimilars.