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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 French National Agency for Medicines and Health Products Safety, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), offers a scientific advice service to assist pharmaceutical companies in the development of health products. This service provides guidance on scientific, technical, regulatory, and legal aspects, aiming to facilitate the development and market access of innovative health products.

The National Agency for the Safety of Medicines and Health Products (Agence nationale de sécurité du médicament et des produits de santé, ANSM) plays a role in improving patient access to new therapies in France. By implementing regulatory procedures and offering scientific support, the agency aims to ensure timely access to treatments while maintaining safety and efficacy standards.

France has implemented early access programmes to provide patients with innovative medicines before full marketing authorisation or reimbursement. These programmes include the Early Access Authorisation (AAP), Compassionate Access Authorisation (AAC), and Compassionate Prescription Framework (CPC). They are designed to address serious, rare, or disabling diseases lacking appropriate treatment options, ensuring timely access to potentially life-saving therapies.

The Early Access to Medicines Scheme (EAMS) is a UK initiative established by the Medicines and Healthcare products Regulatory Agency (MHRA) to provide patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation but address unmet medical needs. 

The Heads of Medicines Agencies (HMA) is a collaborative network comprising the heads of National Competent Authorities (NCAs) responsible for regulating medicinal products for human and veterinary use within the European Economic Area (EEA).

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 Innovative Licensing and Access Pathway was launched in January 2021 by the MHRA to speed up the development and delivery of innovative medicines, and it is due to be relaunched in March 2025. It provides a collaborative framework among the MHRA, the national HTA bodies of the UK and, in the revised ILAP, the National Health Service (NHS). The scheme is designed to streamline access to new therapies that meet unmet medical needs, ensuring transformative treatments reach patients more swiftly.

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.

A Marketing Authorisation (MA) confirms that a regulatory authority, such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), has evaluated a medicinal product and permits its marketing. The assessment verifies adequate quality, safety, and efficacy for the specified use, based on a positive benefit-risk determination. While procedures differ, key stages are common across major agencies.

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 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.

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.

National Competent Authorities (NCAs) in the European Union (EU) work closely with the European Medicines Agency (EMA) to regulate the development, authorisation, and post-marketing surveillance of medicinal products. Their shared objective is to maintain high standards of quality, safety, and efficacy. This cooperation underpins the EU’s legal framework for medicines and applies across the product lifecycle, from initial development through to monitoring of products already on the market.

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