Guidelines

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In March 2019, the US Food and Drug Administration (FDA) issued a new draft guidance document concerning non-proprietary name suffixes for biological products [1].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Health Canada issues draft guidance on generics labelling and equivalence

Canada’s federal department responsible for health, Health Canada, has issued two new draft guidance documents for public consultation as part of the agency’s effort to clarify the eligibility criteria for its abbreviated new drug submission (ANDS) pathway for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The US Food and Drug Administration (FDA) has issued a new draft guidance document concerning non-proprietary name suffixes for biological products.

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].

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).

FDA releases new guidance to speed up generics approvals

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

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.

WHO asks for comments on new biosimilar Q&A

As part of plans to provide additional clarification of its 2009 guidelines on the evaluation of biosimilars, the World Health Organization (WHO) has drafted a new document providing answers to questions that regulators have posed over the past eight years.

FDA issues final guidance on ANDA/PAS amendments

The US Food and Drug Administration (FDA) has issued final guidance outlining the agency’s review goals for amendments to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) under Generic Drug User Fee Amendments II (GDUFA II).

FDA issues guidance for labelling biologicals and biosimilars

The US Food and Drug Administration (FDA) has issued two new guidance documents that provide recommendations to industry on labelling requirements for biologicals and biosimilars.

FDA issues final guidance on biosimilar user fees

The US Food and Drug Administration (FDA) has issued final guidance on the agency’s Biosimilar User Fee Act (BsUFA) II fee structure finalizing the changes introduced since BsUFA I.

FDA withdraws biosimilar statistical guidance

The US Food and Drug Administration (FDA) announced on 21 June 2018 that it had withdrawn the draft guidance on analytical studies of biosimilars. The agency does, however, plan to issue an amended version that ‘will reflect state-of-the-art techniques in the evaluation of analytical data’ and give sponsors ‘appropriate flexibility’.

FDA issues draft guidance on biosimilar meetings

The US Food and Drug Administration (FDA) has issued new draft guidance that provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products.

FDA issues guidance on quality considerations for inhaled drugs

The US Food and Drug Administration (FDA) has issued draft guidance on quality considerations for inhaled drugs.

Global guidelines for biosimilars

Last update: 15 June 2018

The public health arm of the United Nations is World Health Organisation (WHO).

WHO, via its biological standardisation programme, develops guidelines and recommendations on the production and control of biological products and technologies.

FDA issues guidance on good manufacturing practice for APIs

The US Food and Drug Administration (FDA) has finalized revised guidance on good manufacturing practice (GMP) for active pharmaceutical ingredients (APIs).

FDA issues final guidance on bioanalytical method validation

On 21 May 2018, the US Food and Drug Administration issued final guidance on bioanalytical method validation.

TGA proposes changes to biologicals regulations

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA) announced on 20 April 2018 the release of proposed amendments to its biologicals regulations that are set to take effect on 1 July 2018.

Regulation of biologicals in Colombia

Since the introduction of Decree 1782 Colombia has been moving towards a new regulatory landscape for biologicals (productos bioterapéuticos) and similar biotherapeutic products (productos bioterapéuticos similares) in the country [1].

EMA opens public consultation on GMP non-compliance template

The European Medicines Agency (EMA) announced on 3 April 2018 that it had opened a public consultation concerning the European Union (EU) template for good manufacturing practice (GMP) non-compliance statement.

FDA releases 52 new and revised bioequivalence guidelines for generic drugs

As part of its ongoing efforts to provide product-specific guidance for generics makers the US Food and Drug Administration (FDA) has again released several new and revised bioequivalence documents. The agency announced on 1 February 2018 that it had released 35 new draft guidance documents and 22 revisions to guidance documents on bioequivalence requirements for the development of generics containing 49 different active ingredients.

FDA issues guidance on co-crystals and impurities

The US Food and Drug Administration has finalized new guidance establishing co-crystals as a drug product intermediate. The agency has also released new information on when to submit elemental impurity data, acknowledging that new guidelines on reporting elemental impurities had slowed approvals in January 2018.

China adopts ICH guidelines and collaborates with UK

As of 1 February 2018, the China Food and Drug Administration (CFDA) will be adopting five safety and regulatory guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). China became the eighth member of ICH in June 2017, which marked a significant expansion of ICH’s impact and aim to promote global public health.

FDA agrees to meet GAO demands on revised guidance for complex generics

The US Government Accountability Office (GAO) released a report on 16 January 2018, in which it stated that the US Food and Drug Administration (FDA) should release plans to issue or revise guidance for complex generic drugs. FDA made an official response in which it laid out its plans for the future which address many of the GAO's concerns.

China FDA issues draft guidance on drug review and approval transparency

China Food and Drug Administration (CFDA) announced on 16 January 2018 that it had issued draft guidance on the public disclosure of information related to its review and approval of drug applications.

EMA regulatory guidance update to prepare for Brexit

In preparation for the UK’s withdrawal from the European Union (EU), set to take place on 29 March 2019, the European Medicines Agency (EMA) and the European Commission have issued regulatory guidance to pharmaceutical companies. The EU wants to ensure that pharmaceutical companies plan for Brexit to avoid any impact on the continuous supply of medicines within the EU.

FDA updates its list of drugs without generics

The US Food and Drug Administration (FDA) announced in December 2017 that it had updated its list of drugs without generics.