Regulatory Requirements of EU & MHRA

The regulatory landscape governing the pharmaceutical industry plays a critical role in ensuring the safety, efficacy, and quality of medicinal products. In the European Union (EU), regulatory requirements are established by the European Medicines Agency (EMA), while the Medicines and Healthcare Products Regulatory Agency (MHRA) oversees the regulation of medicines in the United Kingdom (UK). 

This article provides a comprehensive overview of the regulatory requirements imposed by the EU and MHRA, highlighting their significance in safeguarding public health and promoting innovation in the pharmaceutical sector.

EU Regulatory Requirements

The EU regulatory framework for medicinal products is primarily governed by the European Union Directive 2001/83/EC, as amended, and the European Union Regulation (EC) No 726/2004. These regulations provide a harmonized system for the authorization, registration, and post-marketing surveillance of medicinal products across the EU member states.

• A regulation is a legal act of the European Union that becomes immediately enforceable as law in all member states simultaneously.
• The role of regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their Country,
• it not only includes the process of regulating and monitoring the drug but also the process of manufacturing, distribution, and arid promotion of it.
• Established under the name in 1992 by the treaty on European Union (the Maastricht Union).

European Medicines Agency (EMA) is a decentralized agency of the European Union.

• EMA protects public and animal health by ensuring that all medicines available on the EU market are safe, effective, and of high quality.
• The agency is responsible for the Scientific evaluation, supervision, and safety monitoring of the medicines developed by pharmaceutical Companies for the use in EU.
• EMA and the member states cooperate and share expertise in the assessment of new medicines and new safety information.

Marketing Authorization

The central pillar of EU regulatory requirements is the marketing authorization process. The centralized procedure grants a single marketing authorization valid throughout the EU, ensuring consistent access to safe and effective medicines. The decentralized and mutual recognition procedures allow for national approvals based on the evaluation of the reference member state's assessment report.

• To protect public health and ensure the availability of high-quality, safe, and effective medicines for European citizens, all medicines must be authorized before they can be placed in the market in the EU.
• The agency’s Committee for a medicinal product for Human Use (CHMP) or Committee for medicinal product fur veterinary use (CVMP) carries out a scientific assessment of the application and gives a recoin men da I ion to the European Commission on whether or not to grant a marketing authorization.

Role of EMA

EMA plays an important role in the regulation of medicines in the EU. On the basis of scientific assessments earned out, it grants or refuses, changes or suspends marketing authorization for medicines that have been submitted via the centralized procedure.

The European Commission can also take action concerning other aspects of medicine regulation.

1. Right of Initiative: it can propose new or amended legislation for the pharmaceutical sector.
2. Implementation: It can adopt implementing measures as well as oversee the correct application of EU law on pharmaceuticals.
3. Global Outreach: it ensures appropriate collaboration with relevant international partners and promotes the EU regulatory system globally.

Guidelines And Scientific Advice

• EMA prepares scientific guidelines in cooperation with experts from its scientific committee and working groups.
• These guidelines reflect the latest thinking on developments in biomedical science.
• They are available to guide the development programs of all medicine developers who wish to submit an application for marketing authorization in the EU and to ensure that medicines are developed consistently and to the highest quality.
• EMA also gives product-specific scientific advice to companies for the development of medicines.

Authorization And Supervision of Manufacturers

• Manufacturers, importers, and distributors of medicines in 1 lie ELI must be Licensed before they can cany out those activities.
• The regulatory authorities of each Member State are responsible for granting licenses for such activities taking place within their respective territories.
• Manufacturers listed in the application of medicines to be marketed in the EU are inspected by an EU competent authority.
• Inspection outcomes can be accessed by all Member States and are made publicly available across the EU through EudraGMDP.

Safety Monitoring of Medicines

• The European regulatory system for medicines monitors the safety of all medicines that are available on the European market throughout their life span.
• All suspected side effects that are reported by patients and healthcare professionals must be entered into EudraVigi lance, the EU web-based information system operated by EMA that collects, manages, and analysis reports of suspected side effects of medicines.
• These data are continuously monitored by EMA and the Member States in order to identify any new safety information.

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MHRA

What is MHRA?

The Medicines and Healthcare Products Regulatory. Agency (MHRA) is an executive agency of the Department of Health of the United Kingdom.

The MHRA was set up in April 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).

The MHRA is responsible for ensuring that medicines and medical devices work, and are acceptably safe*

Function of MHRA

The MHRA has no interest in this early stage of drug development

• Performulation and laboratory tests.
• Drug discovery
• Mechanism of action

MHRA comes into play when the company wants to start clinical trials in patients.

• Clinical trials

Function of MHRA

• Regulation of clinical trials
• Safety and efficacy monitoring
• Providing information to public and health professionals
• Enforcement of law
• Licensing

1. Manufacturer and dealer licenses
2. Clinical trial licenses
3. Parallel import licenses

Aims of MHRA

• Protection: Public health through regulation, with acceptable benefit-risk profiles for medicines and devices.
• Promoting: Public health by helping people who use these products to understand their risks and benefits.
• Improving: Public health by encouraging and facilitating developments in products that will benefit people.

Objectives of MHRA

• Safeguard public health through MHRA’s primary role in ensuring that products MHRA regulates meet required standards, that they work, and are acceptable and safe.
• Carry out communication rules through the provision of accurate, timely, and authoritative information to healthcare professionals, patients, and the public.
• Support research, ensuring through the application of the Better Regulation principle that regulation does not stifle innovation.
• Influence the shape of the future regulatory framework through the use of our effective European and International relationships.
• Run an organization with a skilled and equipped workforce that is fit for the future.

The MHRA’s activity

• Assessing the safety, quality anti-efficacy of medicines. and authorizing their sale or supply in the UK for human use.
• Overseeing the UK Notified Bodies that audit medical device manufacturers.
• Operating post-marketing surveillance and other systems for reporting, investigating, and monitoring adverse reactions to medicines and adverse incidents involving medical devices.
• Regulating clinical trials of medicines and medical devices.
• Monitoring and ensuring medicines and medical devices.
• Promoting good practice in the safe use of medicines and medical devices.
• Managing the General Practice Research Database (GPRD) and the British Pharmacopoeia (BP) and contributing to the development of performance standards for medical devices.
• Offering scientific, technical, and regulatory advice on medicines and medical devices.

What MHRA regulates?

Medicine

• Licensing medicines
• Medicines for children
• Inspection and Standards
• Importing and exporting medicines
• Best practice guidance on labeling and packaging of medicines

The role of MHRA

• Assess application Ibr marketing medicinal products.
• Assess applications to undertake clinical trials.
• Inspect the manufacturers and wholesalers of medicines licensing.
• Undertaken post-marketing surveillance including:

1. Pharmacovigilance
2. Quality defect monitoring
3. Sampling and testing
4. Product recalls

MHRA Regulatory Requirements

Following the UK's withdrawal from the EU, the MHRA has assumed regulatory responsibilities previously governed by the EMA. The MHRA has established its own regulatory framework, aligning with international standards while maintaining a commitment to patient safety and public health.

Conclusion

The EU and MHRA regulatory requirements play a vital role in ensuring the safety, efficacy, and quality of medicinal products available to patients within the EU and the UK. By setting robust standards for marketing authorization, clinical trials, pharmacovigilance, and good manufacturing practices, these regulatory bodies promote public health and provide a framework that encourages innovation and access to safe and effective medicines. Pharmaceutical companies must remain vigilant in complying with these requirements to navigate the complex regulatory landscape and contribute to the betterment of global healthcare.

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