Guidelines

Biosimilar User Fee Act (III) performance goals letter published

Home/Guidelines | Posted 22/10/2021

In mid-September 2021, the US Food and Drug Administration (FDA) released the Performance Goals Letter for the Biosimilar User Fee Act (BsUFA) III (FY2023 – FY2027) [1].

FDA updates generics guidance due to COVID-19 pandemic

Home/Guidelines | Posted 01/10/2021

On 8 September 2021, the US Food and Drug Administration (FDA) revised its questions and answers guidance on generic drug development and abbreviated new drug application (ANDA) submissions during the COVID-19 public health emergency.

WHO guidelines on pharmaceutical pricing policies

Home/Guidelines | Posted 24/09/2021

The World Health Organization (WHO) has issued a new plain language summary on country pharmaceutical pricing policies, as part of its efforts to promote the use of high-quality generic and biosimilar medicines.

Mexico introduces new decree on health regulation

Home/Guidelines | Posted 27/08/2021

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.

UK’s MHRA updates its guidance on licensing biosimilars

Home/Guidelines | Posted 16/07/2021

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.

Draft decree for prescribing generics in Costa Rica

Home/Guidelines | Posted 09/07/2021

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.

NICE recommends additional biologicals for rheumatoid arthritis

Home/Guidelines | Posted 02/07/2021

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.

A new decree modifies several aspects of the regulatory approval system for biosimilars in Mexico

Home/Guidelines | Posted 25/06/2021

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’).

Peru issues decree for the registration of medicines and biological products

Home/Guidelines | Posted 21/06/2021

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.

FDA issues final guidance on BCS-based biowaivers

Home/Guidelines | Posted 11/06/2021

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.