Guidelines

FDA releases new guidance on instructions for use for biologicals

Home/Guidelines | Posted 29/07/2022

The US Food and Drug Administration (FDA) has released new guidance on Instructions for Use (IFU) for human prescription drugs and biological products. The guidance is an updated version of a 2019 draft and explains how to create safe and consistent IFUs.

Mexican guidelines for biocomparables

Home/Guidelines | Posted 10/02/2012

Last update:  22 July 2022

The regulatory body for approval of medicines in Mexico is the Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). The agency, created in 2001, is a decentralized organ of the Department of Health with technical, administrative and operational autonomy. It is responsible for protecting the Mexican population against sanitary risks, through sanitary regulation, control and promotion.

Colombian guidelines for productos bioterapéuticos similares

Home/Guidelines | Posted 19/06/2015

Last update: 17 June 2022

The regulatory body for approval of medicines in Colombia is INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Colombia’s National Institute of Food and Drug Monitoring. It is the national regulatory agency, a technical-scientific surveillance and control body, which works to protect the individual and collective health of Colombians, through the application of health standards associated with the consumption and use of food, medicines, medical devices and other products subject to health surveillance. The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Colombia.

Argentinian guidelines for similar biological medicines

Home/Guidelines | Posted 03/05/2013

Last update: 24 June 2022

The regulatory body for approval of medicines in Argentina is the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Foods and Medical Devices; ANMAT).

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 (Dirección General de Medicamentos, Insumos y Drogas, 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].