Guidelines

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 The agency announced on 1 February 2018 that it had released 35 new draft guidance documents and 22 revisions to guidance documents on bioequivalence requirements for the development of generics containing 49 different active ingredients.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.

FDA guidance aims to encourage abuse-deterrent generic opioids

The US Food and Drug Administration (FDA) has issued new guidance intended to encourage generics makers to make abuse-deterrent formulations of opioids.

Australian guidelines for biosimilars

Last update: 5 January 2018

The regulatory body for therapeutic goods in Australia is the Therapeutic Goods Administration (TGA).

Indian guidelines for ‘similar biologics’

Last update: 5 January 2018

The regulatory bodies responsible for approval of ‘similar biologics’ in India are the Department of Biotechnology (DBT) under the Ministry of Science and Technology through its Review Committee on Genetic Manipulation (RCGM), and the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.

Stakeholders comment on FDA’s draft statistical biosimilarity guidance

The US Food and Drug Administration (FDA) released draft guidance on statistical approaches to evaluate similarity for biosimilars in September 2017 [1]. Comments from stakeholders on the guidance indicate that they want it to be more specific and narrower in scope.

FDA publishes new draft guidance for ADHD generic

In October 2017, the US Food and Drug Administration (FDA) issued new product-specific draft guidance for generic methylphenidate oral extended-release tablets.

India updates its similar biologics guidelines

The Indian Ministry of Health has revised its guidelines for approving ‘similar biologics’. The guideline was updated in order to make the regulatory pathway more robust and to align the guidelines further with global guidelines for biosimilars. The update was seen as essential in order to meet the ‘ever changing global standards’.

FDA releases 52 new and revised bioequivalence guidelines for generics

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 18 October 2017 that it had released 33 new draft guidance documents and 19 revisions to guidance documents on bioequivalence requirements for the development of generics containing 47 different active ingredients.

New guidelines expected to encourage generics in China

New guidelines have been finalized in China to try and make the country a more drug-friendly market, while also promising progress in the use of generics.

FDA draft guidance clarifies when a 505(b)2 application can be submitted

The US Food and Drug Administration (FDA) has issued new draft guidance intended to help companies determine whether to submit an abbreviated new drug application (ANDA), i.e. 505(j), or a 505(b)(2) application.

Canadian guidelines for biosimilars

Last update: 20 October 2017

The regulatory body for approval of biologicals in Canada is the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch (HPFB) of Health Canada.

FDA issues draft guidance on statistical approaches to evaluating similarity for biosimilars

The US Food and Drug Administration (FDA) has released draft guidance, which the agency says, when finalized, will provide advice on the evaluation of analytical similarity for biosimilars.

New EMA reflection paper on setting dissolution specifications

The European Medicines Agency (EMA) released a reflection paper on 15 August 2017 which will help generic drugmakers to set specifications for the in vitro dissolution of immediate-release oral drugs.

New FDA guidance on biological manufacturing changes

The US Food and Drug Administration (FDA) has released draft guidance on post-approval manufacturing changes for biological products, which outlines which changes have the least potential to affect product quality and how to document them in an annual report.

Physician associations comment on FDA’s interchangeability guidance

The US Food and Drug Administration (FDA) received 52 comments on its draft guidance on the interchangeability of biosimilars with their reference biologicals.

Comments on switching in FDA’s interchangeability guidance from big pharma

The US Food and Drug Administration’s (FDA) comment period on its guidance on the interchangeability of biosimilars with their reference biologicals ended on 19 May 2017 [1].

Comments on extrapolation in FDA’s interchangeability guidance from big pharma

19 May 2017 marked the end of the comment period on the US Food and Drug Administration’s (FDA) guidance on the interchangeability of biosimilars with their reference biologicals [1].

Big Pharma comments on FDA’s interchangeability guidance

The comment period on the US Food and Drug Administration’s (FDA) guidance on the interchangeability of biosimilars with their reference biologicals ended on 19 May 2017 [1].

Comments on FDA’s interchangeability guidance

The US Food and Drug Administration (FDA) finally issued its much anticipated guidance on the interchangeability of biosimilars with their reference biologicals in January 2017 [1]. FDA initially released the document for a 60-day comment period (until 20 March 2017), but subsequently extended the period until 19 May 2017 [2].

FDA to speed up review of priority generics

As part of the Generic Drug User Fee Amendments Reauthorization (GDUFA II) recently agreed with industry [1], the US Food and Drug Administration (FDA or Agency) has released guidance outlining how sponsors can qualify for shorter review times for priority generics.

EMA adopts five product-specific bioequivalence guidelines

The European Medicines Agency (EMA) has adopted five product-specific guidance documents on the demonstration of bioequivalence. The guidelines were published on 10 July 2017 and will become effective from 1 January 2018.

FDA releases 37 new and revised bioequivalence guidelines for generics

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 15 May 2017 that it had released 21 new draft guidance documents and 16 revisions to guidance documents on bioequivalence requirements for the development of generics containing 33 different active ingredients.

FDA asks for comments on reauthorization of BsUFA

The US Food and Drug Administration (FDA) is seeking public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication (Program) for original biologics license applications (BLAs). The program is part of the FDA’s commitments under the proposed reauthorization of the Biosimilar User Fee Act (BsUFA).

Apotex petitions FDA over Neulasta biosimilars

Apotex, and its specialist biosimilars unit Apobiologix, submitted a Citizen Petition on 21 April 2017 to the US Food and Drug Administration (FDA). The petition requests that the agency requires all biosimilar applicants referencing Neulasta (pegfilgrastim) to ‘conduct their comparative clinical efficacy studies (including pharmacokinetics (PK) and pharmacodynamics (PD) studies and immunogenicity studies) in at least one intended patient population’.

EMA biosimilars guidance for healthcare professionals

The European Medicines Agency (EMA) announced on 5 May 2017, during the agency’s third stakeholder event on biosimilars, that it had introduced a new information guide on biosimilars for healthcare professionals.

FDA extends comment period for interchangeability guidance

In a Federal Register notice published on 15 March 2017 the US Food and Drug Administration (FDA) announced that it would be extending the comment period on its draft guidance on the interchangeability of biosimilars with their reference biologicals. This change came after the agency received requests for an extension. 

FDA recommends minimal design changes for generic drug delivery products

The US Food and Drug Administration’s (FDA) latest guidance for industry provides recommendations for manufacturers seeking approval for generic versions of ‘drug-device combination products’, such as auto injectors.

FDA rejects petitions over biologicals naming guideline

The US Food and Drug Administration (FDA) has rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same non-proprietary names as their reference products.

New FDA guidance to speed up generics approvals

Updated guidance released by the US Food and Drug Administration (FDA) renews the criteria for receiving generic drug applications and downgrades certain deficiencies to ease the pressure on industry. 

FDA issues final guidance on naming biologicals

The US Food and Drug Administration (FDA) has issued final guidance detailing the agency’s requirements for the non-proprietary naming of biological products.

FDA issues draft guidance on biosimilar interchangeability

The US Food and Drug Administration (FDA) has finally issued its much anticipated guidance on the interchangeability of biosimilars with their reference biologicals.

FDA issues final guidance on pharmacology data for biosimilarity

The US Food and Drug Administration (FDA) on 29 December 2016 published final guidance outlining the clinical pharmacology data necessary to support a biosimilar application.

Biosimilars interchangeability guidance expected by end 2017

The US Food and Drug Administration (FDA) is not likely to produce draft guidance on interchangeability of biosimilars before the end of 2017.

FDA issues final guidance on pharmacology labelling

The US Food and Drug Administration (FDA) on 2 December 2016 published final guidance for completing the clinical pharmacology section of labelling for human prescription drugs, which includes originator drugs, generics and biologicals.

FDA releases 67 new and revised bioequivalence guidelines for generics

As part of its ongoing efforts to provide product specific guidance for generics makers the US Food and Drug Administration (FDA) has again released a whole host of new bioequivalence documents. The agency announced on 1 October 2016 that it had released 34 new draft guidance documents and 33 revisions to guidance documents on bioequivalence requirements for the development of generics containing 59 different active ingredients.

FDA issues guidance on self-identification for generics makers

The US Food and Drug Administration (FDA) announced on 22 September 2016 that it had published a guidance document clarifying its expectations on self-identification for generics makers.

Regulations for biosimilars in South Korea

The legislative basis for the regulation of biosimilars and its guideline for evaluation of biosimilars in South Korea was established in 2009 [1, 2].

Naming requirements in Australian biosimilars guidance

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), published specific guidance for biosimilars on its website on 30 July 2013. Included in this guidance is a section on naming conventions for biosimilars.

Australia issues new biosimilars guidance

Australia’s regulatory body, the Therapeutic Goods Administration (TGA) published specific guidance for biosimilars on its website on 30 July 2013.

Development and regulation of biosimilars in Japan

In Japan, a biosimilar product is defined as a biotechnological drug product developed by a different company that is comparable to the approved biotechnology-derived product (reference product) of an innovator company [1, 2].

South Korean guidelines for biosimilars

Last update:  10 April 2015

The regulatory body for approval of medicines in South Korea is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration. The agency, through its Biopharmaceuticals and Herbal Medicines Bureau, is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the South Korea.

ACR asked for guidelines on biosimilar substitution

At the US Food and Drug Administration’s (FDA) latest meeting on Biosimilar User Fee Act Reauthorization (BsUFA II), the American College of Rheumatology (ACR) asked FDA to create guidelines for biosimilar substitution.

Japanese guidelines for biosimilars

Last update: 21 October 2016

The Ministry for Health Labour and Welfare (MHLW) is the regulatory body in Japan responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Japan and makes the decision on approval of drugs, including biologicals.

Australia to adopt EMA generics guidelines

The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 10 April 2015 that it was carrying out public consultations on the adoption of European Union (EU) guidelines in Australia.