Guidelines

New decree for the prescription and commercialization of medicines in Argentina

Home/Guidelines | Posted 11/03/2024

Through Decree 63/2024, published on 22 January 2024, in the Official Gazette of the Argentine Republic, progress began on the regulation of the Decree of Need and Urgency (DNU). DNU 70/23 regarding articles related to the prescription of medications and their commercialization. Likewise, work is also being done on upcoming regulations.

FDA issues draft guidance on biosimilars and interchangeable biosimilars labelling

Home/Guidelines | Posted 22/09/2023

The US Food and Drug Administration (FDA) announced on 15 September 2023, the availability of a draft guidance for industry entitled ‘Labeling for Biosimilar and Interchangeable Biosimilar Products’ [1].

WHO’s revised guideline to safe and effective biosimilar products

Home/Guidelines | Posted 24/02/2023

The review article published by Kang H-N et al. in 2023 presents the key updates that have been incorporated in the World Health Organization (WHO) revised guidelines on evaluation of biosimilars adopted by the WHO Expert Committee on Biological Standardization in April 2022 [1]. The updates include the following but are not restricted to these alone and should be read in conjunction with the guidelines [2]:

New FDA guidance on statistical approaches to establishing bioequivalence

Home/Guidelines | Posted 20/01/2023

In December 2022, US Food and Drug Administration (FDA) updated its draft guidance on statistical approaches to establishing bioequivalence [1]. Following this, the public were given 60 days to comment of the draft.

UK updates guidance to allow biosimilars interchangeability

Home/Guidelines | Posted 13/01/2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) updated its 2021 guidance on biosimilars [1] in November 2022 to allow interchangeability between biosimilars if they use the same reference medicinal product (RP).

Guidelines for the regulation of biologicals, biosimilars and radiopharmaceuticals in Brazil

Home/Guidelines | Posted 01/12/2022

ANVISA (Agência Nacional de Vigilância Sanitária), the National Health Surveillance Agency of Brazil, published in November 2022 three new guidance documents on the regularization of biological, biosimilar and radiopharmaceutical products.

FDA Guidance for Industry updates: more meetings with ANDA applicants

Home/Guidelines | Posted 01/12/2022

As of October 2022, US Food and Drug Administration (FDA) has updated four guidances to address new commitments made in the latest Generic Drug User Fee Amendments (GDUFA III) programme. To enhance the ability to have productive discussion about prospective products, the guidances now include provision to permit and remote meetings between FDA and prospective and current abbreviated new drug application (ANDA) applicants.

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].