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The draft guidance was published in a Federal Register announcement published on 22 May 2019.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In March 2019, the US Food and Drug Administration (FDA) issued a new draft guidance document concerning non-proprietary name suffixes for biological products [1].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Health Canada issues draft guidance on generics labelling and equivalence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.

FDA plans to advance development of complex generics in 2019

Home/Guidelines | Posted 08/03/2019

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

Home/Guidelines | Posted 22/02/2019

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

Home/Guidelines | Posted 15/02/2019

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

Home/Guidelines | Posted 08/02/2019

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

Home/Guidelines | Posted 01/02/2019

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

FDA issues draft guidance on tentatively approved ANDAs

Home/Guidelines | Posted 18/01/2019

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

Home/Guidelines | Posted 11/01/2019

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

Home/Guidelines | Posted 07/12/2018

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

Home/Guidelines | Posted 21/11/2014

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].

Biosimilars makers in South Korea to benefit from new accounting guideline

Home/Guidelines | Posted 16/11/2018

South Korea’s financial authority has released new ‘relaxed’ guidelines for how drugmakers should list research and development ‘R & D’ spending as assets in an attempt to resolve the controversy that has haunted the market since early 2018.

FDA issues guidance for developers of complex generics

Home/Guidelines | Posted 09/11/2018

The US Food and Drug Administration (FDA) announced on 9 October 2018 that it had released new guidance documents as part of its efforts to advance the development of generics of complex drugs with the aim of improving patient access to medicines.

FDA to refer citizen petitions attempting to delay generics to FTC

Home/Guidelines | Posted 26/10/2018

The US Food and Drug Administration (FDA) announced on 2 October 2018 that it had released new draft guidance designed to limit the use of citizen petitions to delay approval of generics and biosimilars. The new guidance informs brand-name drugmakers how the agency would highlight any improper use of these petitions in its annual reports filed with Congress. It also highlights FDA’s intention to refer petitions that it judges as an attempt to delay competition to the Federal Trade Commission (FTC).

FDA releases new guidance to speed up generics approvals

Home/Guidelines | Posted 05/10/2018

The US Food and Drug Administration (FDA) has released a guidance document that aims to reduce the time that it takes for safe and effective generics to reach the market.

FDA releases product-specific guidance to increase generics competition

Home/Guidelines | Posted 21/09/2018

The US Food and Drug Administration (FDA) has issued 54 product-specific draft guidances with the aim of promoting access to generics and increasing drug price competition.

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