Borderline & Combined Products

The European Union-wide procedure for the authorization of medicines, where there is a single application, a single evaluation, and a single authorization throughout the European Union. Only certain medicines are eligible for the centralized procedure, under mandatory or optional scope. 

A streamlined procedure with the possibility of shortened approval times in straightforward cases.  It is possible to end the procedure at any time point taking into account the harmonization of originator SmPCs, the quality of the file, and the assessment report. during the procedure if a consensus is reached.

The regulation of clinical trials aims to ensure that the rights, safety, and well-being of trial participants are protected and the results of clinical trials are credible.  In the EU, approximately 2,800 clinical trials are authorized each year.

Approximately 60% of clinical trials are sponsored by the pharmaceutical industry and 40% mainly by academia.

To qualify for orphan designation, a medicine must meet several criteria. It must be intended for the treatment, prevention, or diagnosis of a disease that is life-threatening or chronically debilitating, the prevalence of the condition in the EU must not be more than 5 in 10,000 patients and the medicine must be of significant benefit to those affected by the condition.

The Regulation aims to ensure that medicines for use in children are of high quality, ethically researched, and authorized appropriately and to improve the availability of information on the use of medicines for children. It aims to achieve this without subjecting children to unnecessary trials or delaying the authorization of medicines for use in adults.

ATMPs are classified into three main types: gene therapy medicines,  somatic-cell therapy medicines, and 

tissue-engineered medicines. Furthermore, some ATMPs may contain one or more medical devices as an integral part of the medicine, which are referred to as combined ATMPs. 

Regulates the rules governing the procedures for post-authorization changes to the terms of a marketing authorization for human medicines.  In June 2024, EU regulators proposed the amendments to the guidelines on the details of the different categories of variations and operation of the variations procedures and invited  all stakeholders to comment.

Contributes to improving the availability for EU patients of innovative technologies in the area of health, such as medicines and certain medical devices. 

It provides a transparent and inclusive framework by establishing a Coordination Group of HTA national or regional authorities.

Before a medicine is authorized for use, evidence of its safety and efficacy is limited to the results from clinical trials. Once it is authorized,  its safety is monitored throughout its use in healthcare practice. EU law therefore requires each marketing authorisation holder, national competent authority, and EMA to operate a pharmacovigilance system. 

The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories:

Q - Quality, S - Safety, E - Efficiency & M - Multidisciplinary.

Includes rules, regulations, procedures, and administrative procedures associated with the FDA, investigational new drug applications, diagnostic radiopharmaceuticals, orphan drugs, bioavailability and bioequivalence requirements, over-the-counter (OTC) drug products, and more.

Regulates medicinal products for human use following the European Community’s medicinal products directive (Directive 2001/83/EC) and UK law. The Medicines and Healthcare Products Regulatory Agency (MHRA) is the UK’s standalone medicines and medical devices regulator since Jan 2021 & Brexit.

Regulates products, services, or solutions that prevent, diagnose, monitor, treat, and care for people.

Regulates non-invasive tests used on biological samples (for example, blood, urine, or tissues) to determine the status of a person’s health.

Regulation (EU) 2024/1689 of the European Parliament laying down harmonized rules on artificial intelligence and amending other relevant regulations.

 In 1982, the US FDA that regulated medical devices and radiation-emitting products merged to form the Center for Devices and Radiological Health (CDRH).

Quality policy. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.

The agreement on mutual recognition concerning conformity assessment certificates and markings, MHRA has with the EU, US, Canada, TGA & New Zealand.

Medical devices — Quality management systems — Requirements for regulatory purposes

Quality management systems – Requirements

The Medical Device Single Audit Program allows to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

Part 1: Evaluation and testing within a risk management process.

Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.

Part 1: Requirements for materials, sterile barrier systems, and packaging systems.

Part 1: Classification of air cleanliness by particle concentration

Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

Application of risk management to medical devices.

Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements.

Medical device software, software life cycle processes.

Application of usability engineering to medical devices