Guidelines

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.

Canada’s federal department responsible for health, Health Canada, has issued two new draft guidance documents for public consultation as part of the agency’s effort to clarify the eligibility criteria for its abbreviated new drug submission (ANDS) pathway for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.

The US Food and Drug Administration (FDA) has issued a new draft guidance document concerning non-proprietary name suffixes for biological products.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.

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.

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.

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.

The US Food and Drug Administration (FDA) wants to enhance the utility of the Orange Book to foster drug competition.

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

The US Food and Drug Administration (FDA) has issued draft guidance to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final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