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REGULATION OF EU BY SHIVAM.pptx

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REGULATION OF EU BY SHIVAM.pptx

  1. 1. Prepared by:- Shivam kumar M.Pharm Ist sem
  2. 2. The Europe Union  A political union also called as Europe union formed in 1993 for purpose of achieving political and economic integration.  The EU includes 28 members states located in Europe.  The EU total population is about 500 millions people. The EU operates through a system of: I. Supranational independent institution. 2. Intergovernmental negotiated decisions by its member of the states .  It is legal entity and can negotiate international agreement on behalf of its member states.  In EU there are two regulatory steps by which a drug is approved in market 1. clinical trials application [approved by both member state level]. 2. Marketting authorisation [ approved by both member state and centralised level]
  3. 3.  Pharmaceutical industry is most regulated of all the industries. Regulation are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug products and costs more than $800 million.  When did this regulation came?  During the 20th century, there were no law’s and regulation to protect public from the unfavorable effects of the drugs.  Misfortune, disaster and tragedy had triggered most of the advances in drug regulation. There are some examples of disaster which leads to the formation of regulation in the industry. *Thalidomide tragedy (1962) *Elixir sulphanilamide (1937) {taste of death} Regulation in the Industry
  4. 4. The Role of EMA  EMA was established in 1995 to ensure the best use of scientific resources across Europe for the evaluation, supervision and pharmacovigilance of medicines  EMA is responsible for the scientific evaluation, primarily of innovative and high-technology medicines developed by pharmaceutical companies for use in the EU.  Experts participate in the work of EMA as members of its scientific committees, working parties, scientific advisory groups  The experts are chosen on the basis of their scientific expertise and many of them are made available to EMA by the NCAs in Member States.  Increasingly, patients and healthcare professionals are involved in the work of the Agency including in the evaluation of medicines.
  5. 5. Registration in Europe Post Nov. 2005:  Three European Systems Centralized Procedure (CP) (via EMA) Mutual recognition procedure (MRP) Decentralized procedure (DCP)
  6. 6. Marketing Authorization 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 on the market in the EU. The European system offers different routes for such an authorization.
  7. 7.  The centralized procedure : allows the marketing of a medicine on the basis of a single EU- wide assessment and marketing authorization which is valid throughout the EU.  Pharmaceutical companies submit a single authorization application to EMA.  The Agency’s committee for medicinal products for human use (CHMP) or committee for medicinal products for veterinary use (CVMP) then carries out a scientific assessment of the application and gives a recommendation to the European commission on whether or not to grant a marketing authorization. Drug approval in Europe Union Centralized procedure:
  8. 8.  Once granted by the European commission, the centralized marketing authorization is valid in all EU member states. The use of the centrally authorized procedure is compulsory for most innovative medicines, including medicines for rare diseases.  Rules and Requirements applicable to pharmaceuticals in the EU are the same, irrespective of the authorization route for a medicine.  A European public Assessment report, (EPAR), is published for every human or veterinary medicine that has been granted for refused a marketing authorization following an assessment by EMA.  Drug approval in Europe Union Centralized process is compulsory for: • Those medicines which are derived from any biotechnology processes, such as genetic engineering • Those medicines which are intended for the treatment of Cancer, HIV/AIDS, diabetes, neurodegenerative disorders or autoimmune diseases and other immune dysfunctions. • Medicines officially designated 'Orphan medicines' (medicines used for rare diseases).
  9. 9. Drug approval in Europe Union Mutual Recognition Procedure: Mutual-recognition procedure where companies that have a medicine authorised in one EU Member States can apply for this authorisation to be recognised in other EU countries. This process allows Member States to rely on each other’s scientific assessments. The Mutual Recognition procedure allows applicants to obtain a marketing authorization in the concerned member states (CMS) other Than the Reference member state (RMS), where the drug is previously approved.
  10. 10. • Applicant submits identical dossier to all EU member states in which they want marketing 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.
  11. 11. Drug approval in Europe Union Decentralized procedure The decentralised procedure where companies can apply for the simultaneous authorisation of a medicine in more than one EU Member State if it has not yet been authorised in any EU country and does not fall within the scope of the centralised procedure;
  12. 12. 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 EU country and essentially do not fall within the centralized procedure’s essential drugs list. • Based on the assessment report which is prepared by the RMS & any comments made by the CMS, marketing authorization should be granted in accordance with the decision taken by the RMS & CMS in this decentralized procedure. • Generally used for those products that has not yet received any authorisation in an EU country. • Time: 210 days.
  13. 13. Drug approval in Europe Union 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.
  14. 14. DCP FLOW CHART Applicant submits application to the RMS & CMS RMS & CMS validates the application RMS distributes the preliminary assessment report to the CMS RMS sends preliminary assessment report & all comments of the CMS to the applicant
  15. 15. Clock stops, applicant responds, clock runs RMS sends drafts assessment report to the CMS & applicant CMS approve the assessment report Marketing Authorization in RMS & each of the CMS
  16. 16. MRP FLOW CHART Applicant submits application to the RMS & CMS RMS validates the application RMS distributes assessment report to the CMS
  17. 17. CMS approves the assessment report CMS Validates the application Marketing authorization in each of the CMS
  18. 18. The European Commission can also take action concerning other aspects of medicine regulation: • Right of initiative – it can propose new or amended legislation for the pharmaceutical sector; • Implementation – it can adopt implementing measures as well as oversee the correct application of EU law on pharmaceuticals; • Global outreach – it ensures appropriate collaboration with relevant international partners and promotes the EU regulatory system globally.
  19. 19. EMA’s scientific committees The EMA has seven scientific committees that carry out its scientific assessments: • Committee for Medicinal Products for Human Use (CHMP) • Pharmacovigilance Risk Assessment Committee (PRAC) • Committee for Medicinal Products for Veterinary Use (CMVP) • Committee for Orphan Medicinal Products (COMP) • Committee on Herbal Medicinal Products (HMPC) • Committee for Advanced Therapies (CAT) • Paediatric Committee (PDCO)
  20. 20. NATIONAL COMPETENT AUTHORITIES  The national competent authorities (NCAs), responsible for the regulation of human and veterinary medicines in the EU, coordinate their work in a forum called Heads of medicines Agencies (HMA).  The heads of the NCAs work closely with EMA and the European Commission to maximize cooperation and ensure the European medicines regulatory network functions efficiently.  The HMA meets four times per year to address key strategic issues for the network, such as the exchange of information, sharing of best practices, and to streamline mutual recognition and decentralized procedures.
  21. 21. GUIDELINE AND SCIENTIFIC ADVICE  EMA prepares scientific guidelines in cooperation with experts from its scientific committees and working groups.  These guidelines reflect the latest thinking on developments in biomedical science.  This is an important tool to help develop and make available high quality, effective and safe medicines, for the benefit of patients.  Scientific advice can also be given by NCAs.
  22. 22. SAFETY AND 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.  EMA has a committee dedicated to the safety of medicines for human use – the Pharmacovigilance Risk Assessment committee, or PRAC.  If there is a safety issue with a medicines that is authorized in more than one member state, the same regulatory action is taken across the EU and patients and healthcare professionals in all member states are provided with the same guidance.
  23. 23. CLINICAL TRIALS  The authorization and oversight of a clinical trial is the responsibility of the member state in which the trial is taking place. The European clinical trials database (Eudra CT) tracks which clinical trials have been authorized in the EU.  It is used by NCAs and clinical-trial sponsors to enter information protocols and results of clinical trials.  A subset of this information is made publicly available by EMA via the EU clinical trials register.

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