Guidelines

Brazilian guidelines for follow-on biological products

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.

FDA plans to advance development of complex generics in 2019

In a statement released on 30 January 2019, US Food and Drug Administration’s (FDA) Commissioner Scott Gottlieb outlined the steps FDA will take in 2019 to promote access to complex generic medicines.

FDA issues new guidance for accelerated pathway for generics

The US Food and Drug Administration (FDA) announced on 15 February 2019 that it had issued new guidance for its novel accelerated pathway for generics – the Competitive Generic Therapies (CGT) pathway.

ICH proposes harmonization of standards for generics

As part of its efforts on harmonizing guidelines around the world the International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has released a reflection paper on the scientific and technical standards for generics.

FDA to improve Orange Book: issues draft guidance on marketing status

The US Food and Drug Administration (FDA) wants to enhance the utility of the Orange Book to foster drug competition.

European SPC waivers come closer to becoming a reality

A European committee has voted in favour of waivers for Supplementary Protection Certificates (SPCs)

FDA issues draft guidance on tentatively approved ANDAs

The US Food and Drug Administration (FDA) has issued draft guidance to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval.

FDA releases guidances and proposed rule to advance biosimilars policy framework

The US Food and Drug Administration (FDA) announced on 11 December 2018 that it had released four guidance documents and a proposed rule on the definition of a ‘biological product’.

FDA issues post-CRL meeting guidance for generics makers

In December 2018, the US Food and Drug Administration (FDA) published a new guidance document to assist generics makers with meetings with the agency following the issuance of a complete response letter (CRL).

Chinese guidelines for copy biologicals

Last update: 30 November 2018

Since 2018, the China National Drug Administration (CNDA), formerly the China Food and Drug Administration (CFDA, 国家食品药品监督管理局) is the Chinese authority that oversees all drug manufacturing, trade, and registration [1].