Guidelines

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FDA to improve Orange Book: issues draft guidance on marketing status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FDA issues draft guidance on tentatively approved ANDAs

The US Food and Drug Administration (FDA) has issued draft guidance to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final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

Biosimilars makers in South Korea to benefit from new accounting guideline

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

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

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).