Guidelines

Peruvian guidelines for productos biológicos similares

Home/Guidelines | Posted 24/05/2013

Last updated: 20 May 2022

The regulatory body responsible for approving biological drugs in Peru is the General Directorate of Medicines, Supplies and Drugs (DIGEMID) of the Peruvian Ministry of Health ((Ministerio de Salud; MINSA).

FDA releases new guidance on bioavailability studies

Home/Guidelines | Posted 29/04/2022

The US Food and Drug Administration (FDA) has released new guidance on submitting bioavailability information for drug products in investigational new drug applications (INDs) and new drug applications (NDAs).

FDA issues draft guidance on immunogenicity labelling

Home/Guidelines | Posted 11/02/2022

The US Food and Drug Administration (FDA) announced on 3 February 2022 the availability of a draft guidance for industry entitled ‘Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format’.

Guide for the comparability assessment of biological drugs in Colombia

Home/Guidelines | Posted 17/12/2021

Biological drugs have been a breakthrough in the treatment of many diseases, but their cost is usually high, so the development and approval of similar biotherapeutic products has greatly facilitated access for patients, especially in developing countries. That is why Colombia issued guidelines including all these similar biotherapeutic products [1].

FDA issues new guidance on biosimilar development and the BPCI Act

Home/Guidelines | Posted 19/11/2021

The US Food and Drug Administration (FDA) has published final guidance on ‘Questions and Answers on Biosimilar Development and the BPCI Act’ and draft guidance on ‘New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)’.

Decree signed in Costa Rica for the use of generic name in medicines

Home/Guidelines | Posted 29/10/2021

The Costa Rican Ministry of Health has been pushing since 2018 the decree of the 'Regulations for the Prescription and Dispensing of Medicines in Conformity with their International Nonproprietary Name (INN)’ for the Costa Rican private market [1].

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.