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ANMAT logo V13E03

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.

Label prescription drugs

FDA issues draft guidance on biosimilars and interchangeable biosimilars labelling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The US Food and Drug Administration (FDA) announced on 15 September 2023, the availability of a draft guidance for industry entitled ‘Labeling for Biosimilar and Interchangeable Biosimilar Products’ [1].

Guidance V13F21

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]:

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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In December 2022, US Food and Drug Administration (FDA) updated its draft guidance on statistical approaches to establishing bioequivalence [1].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.

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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).

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.