REGULATORY REQUIREMENTS FOR MHRA detail .pptx

REGULATORY REQUIREMENTS OF MHRA

1. REGULATORY REQUIREMENTS OF MHRA PRESENTED BY NIVEDITHA G 1 st Mpharm(pharmaceutics) NARGUND COLLEGE OF PHARMACY

2. MHRA MEDICINES AND HEALTH CARE PRODUCTS REGULATORY AGENCY History of MHRA MCA (Medicines Control Agency) was UK licensing authority, part of the Department of Health, responsible for safeguarding public health by ensuring that all medicines meet acceptable standards, and responsible for clinical trial. MHRA (Medicines and Healthcare products Regulatory Agency) was formed in 2003 with the merger of the MCA (Medicines Control Agency) and the MDA (Medical Devices Agency).

3. In April 2003, it merged with the National Institute for Biological standards and Control (NIBSC) and was rebranded with MHRA identity being used solely for the regulatory center with in the group. MHRA: The MHRA (Medicines and Healthcare Products Regulatory Agency) of the Department of Health and Social care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The medicines and Healthcare Products Regulatory Agency (MHRA) regulate medicines, medical devices and blood components for transfusion in the UK

4. RESPONSIBILITIES OF MHRA Ensuring that medicines, medical devices, and blood components for transfusion meet applicable standards of safety, quality and efficacy. Ensuring that the supply chain for medicines, medical devices and blood components is safe and secure. Promoting international standardization and harmonization to assure the effectiveness and safety of biological medicines.

5. Helping to educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components leading to safer and effective use. Supporting innovation and research development that helps for public health. Influencing UK,EU and international regulatory frameworks so that they are risk reducing and effective at protecting public health.

6. ROLE OF MHRA Operate post-marketing surveillance for reporting, investigating and monitoring of ADR to medicines and incidents with medical devices. Assessment and authorization of medical products for sale and supply in UK. Operate a quality surveillance to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed medicines. Monitor and ensure compliance with medicines and medical devices. Regulate clinical trials of medicines and medical devices

7. Undertake post marketing surveillance includes Pharmacovigilance Quality defect monitoring Sampling and testing Product recalls

8. MEMBERS OF MHRA MHRA Governance / Membership: The Agency board is made up of Non-executive Chairman. 6- Non executive members and Agency’s Chief Executive officer. The agency’s Chief Executive officer is responsible for Service delivery and resources. The Executive Board consisting of the Agency’s directors. The Executive Board’s primary responsibility is to ensure strategic direction set by the Agency board is implemented and reflected in the day operations of the Agency.

9. Functions of MHRA Regulation of clinical trials. Safety and efficacy monitoring. Providing information to public and health professionals. Licensing ▪ Manufacture and dealer licenses. ▪ Clinical trial licenses. ▪ Parallel import licenses.

10. LICENSING PROCESS

11. MARKETING AUTHORIZATION Before any medicine can be used to treat people in the UK, a marketing authorization, from the MHRA is required. The MHRA operates a system of licensing before the marketing of medicines. Medicines which meet the standards of safety, quality and efficacy are granted a marketing authorization (previously a product license), which is normally necessary before they can be prescribed or sold.

12. Product Require Market Authorization New biological or chemical compounds. Different brands of existing medicines. Generics New dosage forms of existing medicines. New uses for existing medicines such as different conditions.

13. Renewal of License New Marketing Authorizations (MAs) are valid for five years and then may be renewed on the basis of re-evaluation of the risk-benefit balance. Once renewed the marketing authorization will be valid for an unlimited period. Applications for renewal should be submitted at least six months before expiry.

14. Cancellation of License If MAs holder does not file an application for renewal within specified time, MAs expires automatically. If the MAs holder does not wish to renew, a letter should be sent indicating cancellation to Administrative support team MHRA has authority to cancel license of products if it affects public health.

15. Post Marketing Surveillances and Yellow Card Scheme Once the newly licensed medicine is in general use, it will be carefully monitored for safety. All medicines have a Patient Information Leaflet (PIL), which gives instruction on how the medicines should be used and on its side effects. In UK, the Yellow Card Scheme is used by doctors and members of the public to report unwanted side effects of a medicine to MHRA. The MHRA, the manufacturer or a medical specialist may investigate the problem depending on how serious it is. It will be recorded to help prevent similar incidents in future, even if it is not investigated.

16. THANK YOU