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The Access Consortium is a collaboration of five national regulatory agencies (MHRA, TGA, Health Canada, HSA, and Swissmedic) that work together to align regulatory processes and reduce duplication in drug evaluations. Its purpose is to enhance international cooperation, ensuring timely access to high-quality, safe, and effective therapeutic products across member countries.

The European Bolar exemption is a legal provision that allows pharmaceutical companies to conduct research and testing on patented drugs without being considered as infringing the patent. This exemption is particularly relevant for the development of generic and biosimilar medicines.

EU support for small and medium-sized enterprises (SMEs) is given primarily through the European Medicines Agency (EMA)’s marketing authorisation processes. The EMA operates a dedicated framework of incentives for SMEs that develop human or veterinary medicines.

Europe’s pharmaceutical regulatory system unites national authorities and the European Medicines Agency to ensure that only safe, effective, and high-quality medicines reach patients through coordinated approval and monitoring processes.

The Innovative Licensing and Access Pathway (ILAP) is a regulatory initiative led by the MHRA, designed to accelerate the development and approval of innovative medicines. It involves collaboration with the national health technology assessment bodies to coordinate the regulatory approval with technology assessment and allow faster patient access to new innovative treatments.

The National Agency for the Safety of Medicines and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) is the French national authority responsible for ensuring the safety, efficacy, and quality of health products, including medicines, medical devices, and other health-related products. Working closely with the European Medicines Agency (EMA) and operating under the Ministry of Health, the ANSM oversees the entire lifecycle of these products, from development through to post-market surveillance.

The MHRA's 150-day assessment process is an expedited pathway for evaluating national marketing authorisation applications for medicines. This streamlined process aims to accelerate patient access to safe and effective medicines by reducing the standard assessment timeline while maintaining rigorous regulatory standards.

The Accelerated Aligned Pathway is a joint initiative of the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE)s designed to align regulatory licensing and health technology assessment (HTA) for selected medicines, particularly those addressing unmet clinical needs, so that decisions on authorisation and value can be delivered in parallel rather than sequentially.

The MHRA's international recognition procedure enables medicines that have been approved by trusted regulatory authorities — such as the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA) — to receive authorisation in the UK through a streamlined process that acknowledges these prior assessments.

The Medicines and Healthcare products Regulatory Agency (MHRA) offers a comprehensive service for pharmaceutical companies seeking scientific advice during the development of their products. This guidance is intended to help companies optimise their development process and ensure compliance with regulatory requirements.

Each European Union (EU) member state maintains its own national authority for oversight of medicines’ safety and efficacy. These bodies collaborate with the European Medicines Agency (EMA), which leads assessments and coordinates procedures across the EU. This Briefing summarises the respective roles of national and European regulators.

An overview of the common global stages of pharmaceutical marketing authorisation, from pre-submission planning to post-authorisation pharmacovigilance and lifecycle variations, and the interface with HTA and access.

Project Orbis is a global regulatory programme led by the US FDA, designed to speed up the review and approval of promising cancer drugs through collaboration among international regulatory authorities. It enables faster patient access to innovative oncology treatments by allowing for concurrent submission, review, and potential approval across multiple countries.

The Simultaneous National Scientific Advice (SNSA) pilot project is an initiative by the European Union (EU) Innovation Network aimed at enhancing the efficiency and consistency of scientific advice for pharmaceutical development. It enables developers to obtain coordinated national scientific advice from multiple National Competent Authorities (NCAs) concurrently, streamlining the advisory process and fostering alignment among regulatory bodies.

Priority Medicines (PRIME) is a voluntary scheme operated by the European Medicines Agency (EMA) to support the development of medicines that address unmet medical needs in the European Union. Launched in March 2016, it provides early and enhanced interaction between developers and EMA with the aim of optimising evidence generation and facilitating use of accelerated assessment at the time of marketing authorisation.

Why a good working understanding of the regulatory approval process is invaluable to the access practitioner.