Guidelines

FDA planning more guidance for developers of complex generics

As part of its efforts to advance the development of generics of complex drugs with the aim of improving patient access to medicines, the US Food and Drug Administration (FDA) announced that it is planning to release new and revised guidance documents for complex generics.

EMA provides guidance on avoiding nitrosamines in human medicines

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

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

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

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The draft guidance was published in a Federal Register announcement published on 22 May 2019.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

In March 2019, the US Food and Drug Administration (FDA) issued a new draft guidance document concerning non-proprietary name suffixes for biological products [1].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

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

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Health Canada issues draft guidance on generics labelling and equivalence

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

The US Food and Drug Administration (FDA) has issued a new draft guidance document concerning non-proprietary name suffixes for biological products.