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ANVISA V22A14

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 logo V13C22

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.

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Turkish guidelines for follow-on biologicals

Home/Guidelines | Posted 27/04/2012

Last update:  23 July 2024

The regulatory body for approval of medicines in Turkey is the General Directorate of Pharmaceuticals and Pharmacy (GDPP). The agency is responsible, under the authority of the Ministry of Health of the Turkish Government, for the registration, marketing approval/authorisation, pricing of pharmaceuticals, legal classification, control of advertisement for pharmaceutical products as well as inspection of pharmaceutical manufacturers, wholesalers and retail pharmacies. The agency is assisted in its tasks by a number of expert committees.

Label FDA V14b20

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.

COFEPRIS V22D08

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.

ANMAT logo V13E03

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).

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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.

MINSA logo V13E24

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).

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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).

Immunology Serology V18D06

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’.