Medicines and Healthcare products Regulatory Agency(MHRA)

This slide cover basic aspects , regulatory body and marketing authorisation process in uk and European union.

1. Medicines and Healthcare products Regulatory Agency(MHRA) By- Rishabh Agrawal M-pharma sem-1 Roll no 19mph112 Guided by: Dr Tejal Mehta mam

2. What are regulatory bodies In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process , licensing, registration, manufacturing, marketing and labeling of pharmaceutical products like : USFDA(USA) MHRA(UK) TGA(Australia)

3. Continued… CDSCO(central drug standard control organisation) - India HEALTH CANADA - CANADA MCC(medicines control council) - South Africa ANVISA ( Agencia national de vigilancia sanitaria) - Brazil EMEA (European medicines agency) - Europe KFDA(Korean food and drug administration) - South Korea MoH (Ministry of health) - Sri Lanka

4. History of MHRA MCA was UK licensing authority, part of the Department of Health; responsible for safeguarding public health by ensuring that all medicines meet acceptable standards; responsible also for clinical trial exemption or clinical trial certificate. MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, 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 within the group.

5. What is MHRA ? The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive 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 regulates medicines, medical devices and blood components for transfusion in the UK. MCA MDA MHRA

6. What MHRA is responsible for: 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. Helping to educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components. Promoting international standardization and harmonization to assure the effectiveness and safety of biological medicines. Manage the Clinical Practice Research Datalink and the British Pharmacopoeia.

7. Some major role of MHRA

8. 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.

9. Product require Market Authorization:

10. Licensing Process Application of clinical trial Evaluation By MHRA If satisfied If not Clinical trials Asse s m - ent of data by expert If satisfied market authorization given If not satisfied license not granted

11. Types of Market Authorization Procedure: Centralized Procedure Decentralized Procedure Nationalized Procedure Mutual Recognition

12. Centralized Procedure: The centralized procedure is one which allows applicants to obtain a marketing authorization that is valid throughout the EU via single application to EMEA. Features: Results in a single authorization valid in EU. Application evaluated by an assigned Rapporteur. Timeline: EMA opinion issued within 210 days, and submitted to European Commission for final approval. Required for medicine of biotechnology processes , cancer, HIV/Aids, diabetes, orphan medicines,etc .

13. Mutual Recognition Procedure: The Mutual Recognition procedure allows applicants to obtain a marketing authorization in the member states(Concerned Member State) other than the member state (Reference Member State) where the drug is previouslyapproved . Features: Applicant submits identical dossier to all EU member states in which it wants authorization, including required information. As soon as one Member State decides to evaluate the medicinal product (at which point it becomes the "RMS"), it notifies this decision to other Member States (which then become the "CMS"), to whom applications have also been submitted. RMS issues a report to other states on its own findings. Generic industry is the major user of this type of drug approval procedure. This process may consume a time period of 390 days.

14. Nationalized Procedure : Nationalized Procedure the Nationalized procedure is one which allows applicants to obtain a marketing authorization in one member state only. In order to obtain a national marketing authorization, an application must be submitted to the competent authority of the Member State. New active substances which are not mandatory under Centralized procedure can obtain marketing authorization under this procedure. Timeline for this procedure is 210 Days.

15. Decentralized procedure: Using this procedure, companies may apply for authorization simultaneously in more than one EU country for products that have not yet been authorized in any Upcountry and essentially do not fall within the centralized procedure’s essential drugs list.12, 13 Based on the assessment report which is prepared by the RMS & any comments made by the CMS, MA should be granted in accordance with the decision taken by RMS& CMS in this decentralized procedure Features: Generally used for those products that has not yet received any authorization in an EU country. Time require 210 days.

16. Types of application (legal basis): Full application - Article 8(3): Applications for new active substances are described as 'full applications’. Abridged applications: Applications for medicines containing existing active substances are described as 'abbreviated’ or ‘abridged applications’. Existing drugs with new forms, routes and indications Sometimes, although the drug is the same, the new product has a different strength or pharmaceutical form or is used by a different route or for different clinical uses.

17. Continued .. 3) Informed consent and change of ownership applications -10C: For commercial reasons companies may want to take over or duplicate a product license held by another company. Where the first company agrees to this 'informed consent' approach, the second company can get an exact copy license commonly known as a 'piggy-back' license. Alternatively, where the ownership of the company changes hands and the new owners need to take over the old product licenses. These applications are called 'change of ownership' applications.

18. Renewal of license: New Marketing authorizations (MAs) are valid for five years and then may be renewed on the basis of a 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.

19. Renewal of Market Approval: Apply to renew your MA for 5 years application submission via electronic application forms ( eAFs ) Re- evaluation by Head of MHA MAs for lifetime MAs for 5 years It takes at least 3 months to process a renewal

20. 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 the licence , a letter should be sent indicating the cancellation to: Administrative Support Team Medicines and Healthcare products Regulatory Agency (MHRA). MHRA has authority to cancel license of product if it affects public health.

21. References: https://www.gov.uk/guidance/renew-marketing-authorisation-for-a-human-medicine#apply-to-renew-your-ma https: //www.gov.uk/topic/medicines-medical-devices-blood/marketing-authorisations-variations-licensing https://www.gov.uk/topic/medicines-medical-devices-blood Preeti M.Singh and Vandna arora“New Drug Approval Procedure in Different Countries: A Review” https://en.wikipedia.org/wiki/Medicines_and_Healthcare_products_Regulatory_Agency

22. Thank You For your Kind listening