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EMA releases reflection paper for generic oral immediate release products

The European Medicines Agency (EMA) announced on 13 May 2016 the publication of draft guidance on the dissolution requirements for orally administered generics with immediate release characteristics.

FDA issues guidance on data integrity and GMP

The recent flood of data integrity problems identified at the manufacturing sites of drugmakers from India, China and elsewhere has led the US Food and Drug Administration (FDA) to draft new guidance addressing the issue.

FDA issues draft guidance on biosimilars labelling

The US Food and Drug Administration (FDA) announced on 31 March 2016 that it had issued draft guidance for industry on labelling for biosimilars. The guidance is open for comment for a period of two months.

Indian guidelines for ‘similar biologics’

Last update:  15 April 2016

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.

India releases revised guidelines for ‘similar biologics’

On 26 March 2016, India’s Central Drugs Standard Control Organization (CDSCO) announced the release of proposed revised guidance for ‘similar biologics’ in India.

EMA publishes guidance on publication of clinical trials data

The European Medicines Agency (EMA) announced on 3 March 2016 the publication of detailed guidance on the requirements for pharmaceutical companies to comply with the agency’s policy on publication of clinical trials data for medicines.

BSG guidance recommends switching to biosimilar infliximab

The British Society of Gastroenterology (BSG) released new guidance in February 2016 recommending that stable patients be switched to biosimilar infliximab (CT-P13).

FDA releases 47 new and revised bioequivalence guidelines for generics

Generics makers have a whole host of new bioequivalence documents to go through. The US Food and Drug Administration (FDA) announced on 27 January 2016 that it had released 35 new draft guidance documents and 12 revisions to guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients.

FDA finalizes guidance for biosimilars meetings

The US Food and Drug Administration (FDA) announced on 18 November 2015 that it had finalized its guidance for industry on formal meetings between the FDA and biosimilars sponsors.

Health Canada issues draft revised SEB guideline

Canada’s federal department responsible for health, Health Canada, has issued a new draft revised guidance document on the information and submission requirements for subsequent entry biologics (SEBs). The draft guideline, issued on 7 December 2015, provides guidance to sponsors to enable them to satisfy the information and regulatory requirements under the Food and Drugs Act and Regulations for the authorization of SEBs in Canada.

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