Guidelines

EMA provides guidance on avoiding nitrosamines in human medicines

Home/Guidelines | Posted 11/10/2019

On 26 September 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided guidance on avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesized active substances, following a request from EMA’s Executive Director.

FDA organizes workshop on complex generics

Home/Guidelines | Posted 13/09/2019

The US Food and Drug Administration (FDA) has announced that the agency is organizing a workshop on the regulation of complex generics.

Comments on FDA’s plans to transition insulin products

Home/Guidelines | Posted 14/06/2019

The US Food and Drug Administration (FDA) held a public meeting on the 13 May 2019 to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products.

FDA issues guidance on quality-related considerations for biosimilars

Home/Guidelines | Posted 31/05/2019

The US Food and Drug Administration (FDA) has issued draft biosimilar guidance on quality-related considerations.

The draft guidance was published in a Federal Register announcement published on 22 May 2019. It aims to assist biosimilars developers on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product.

Stakeholders question FDA’s guidance on naming biologicals

Home/Guidelines | Posted 24/05/2019

In March 2019, the US Food and Drug Administration (FDA) issued a new draft guidance document concerning non-proprietary name suffixes for biological products [1]. Many stakeholders comments on the document call for a change in policy from the agency when it comes to naming biologicals.

FDA issues final guidance on interchangeable biologicals

Home/Guidelines | Posted 17/05/2019

The US Food and Drug Administration (FDA) announced on 10 May 2019 that it had issued final guidance on the pathway for interchangeable biologicals.

FDA pledges to improve quality of compounded drugs

Home/Guidelines | Posted 10/05/2019

The US Food and Drug Administration (FDA) released a statement on 3 April 2019 detailing its priorities for improving the quality of compounded drugs in 2019.

Health Canada issues draft guidance on generics labelling and equivalence

Home/Guidelines | Posted 03/05/2019

Canada’s federal department responsible for health, Health Canada, has issued two new draft guidance documents for public consultation as part of the agency’s effort to clarify the eligibility criteria for its abbreviated new drug submission (ANDS) pathway for generics.

FDA proposes update to biosimilar naming guideline

Home/Guidelines | Posted 22/03/2019

The US Food and Drug Administration (FDA) has issued a new draft guidance document concerning non-proprietary name suffixes for biological products.

Brazilian guidelines for follow-on biological products

Home/Guidelines | Posted 08/06/2012

Last update: 15 March 2019

The regulatory body for approval of medicines in Brazil is the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), which was created by Law 9782, enacted in 1999. ANVISA is responsible, under the authority of the Ministry of Health–Mínistério de Saúde–of the Brazilian Government, for drug registration and licences to pharmaceutical laboratories and to other companies inside the pharmaceutical production flow. The agency is also responsible for establishing regulations applicable to clinical trials and drug pricing, which is carried out by the Chamber of Drug Market Regulation.