Seminar on… Medicines Control Council (MCC)

1. Seminar on…Medicines Control Council (MCC) Presented By: Mehul N. Padshala M.Pharm. Department of Pharmaceutics and Pharmaceutical technology L. M. College of Pharmacy

2. Content • What is MCC? • Purpose and Operates by • The structure of Council and its committees • Documents and Guidelines

4. What is MCC? • Medicines Control Council • MCC is a statutory body that was established in terms of the Medicines and Related Substances Control Act, 101 of 1965, to oversee the regulation of medicines in South Africa.

5. QUALITY EFFICACY SAFETY Purpose • It is appointed by the Minister of Health • Its main purpose is to safeguard and protect the public through ensuring that all medicines that are sold and used in South Africa are safe,therapeutically effective and consistently meet acceptable standards of quality.

6. The Medicines Control Council applies standards laid down by the Medicines and Related Substances Control Act, (Act 101 of 1965) which governs the manufacture, distribution, sale, and marketing of medicines. • The prescribing and dispensing of medicines is controlled through the determination of schedules for various medicines and substances.

7. Operates by: • External expertswho are members of Council Committee structures • The office of the Registrarprovides administrative and technical support • The Registrar is also anexecutive secretaryto Council • There are four Directorates, which are largely responsible for co-ordination and execution of various activities. • There is also a Deputy Registrar who performs functions as determined by the Registrar.

8. Staff • Includes doctors, pharmacists, veterinarians, other scientists and administrative staff

10. MCC Structure :-

12. Medicines Regulatory Affairs:-

13. Documents

14. Acts and Regulations

15. Medicines and related substances control act 101 of 1965 Same like a D & C Act, India To provide the all information related to the registration of medicines and related substances intended for human and for animal use.

16. Regulation of Act 101 Therapeutic equivalence International Tendering Processing Particulars to be published in the gazette Labelling , Package inserts and Patient information leaflet Prescription book Import and Export Licensing Registration ARD, Price controlling Veterinary Medicines Advertising of Medicines

17. SCHEDULES TO ACT 90 • Classified the drugs in a SEVEN schedules

18. Schedule:

19. Communications to industry

20. ADR Terminology Used In Package Inserts • According to System Organ Classes

21. DHCP-letter • A Dear Health Care Professional • also referred to as a Dear Doctor letter Letter distributed by an applicant or a holder of a certificate of registration for a medicine to medical practitioners and other health care professionals to convey important information about medicines.

22. Contains anysafety informationabout amedicine • Must be submitted to theMCC for review. • The Pharmacovigilance Committee will present all approvals of DHCP letters as part of its report to Council.

23. Fees payable to the Registrar

24. CategoryA Human medicine including biologicals Ready to use CategoryC Veterinary medicines, including biologicals CategoryB Human medicine including biologicals Req. Manipulation Category

25. Forms

26. Document and Reports

27. GMP

28. Why needed?? • Facilitate the removal of barriers to trade in medicinal products, to promote uniformity in licensing decisions and to ensure the maintaining of high standards of quality assurance in the development, manufacture and control of medicinal products • It was agreed to harmonise the rules of GMP applied under Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) • Medicines Control Council of South Africa accepts the European, British or United States Pharmacopoeia.

32. Parametric Release A system of release that gives the assurance that the product is of the intended quality based on information collected during the manufacturing process and on the compliance with specific GMP requirements related to Parametric Release.

33. Human Medicines

34. HUMAN MEDICINES • 2.01 General information • 2.02 Pharmaceutical and analytical • 2.03 Alcohol content of medicines* • 2.04 Post-importation testing* • 2.05 Stability * • 2.06 Biostudies • 2.07 Dissolution* • 2.08 Post registration amendments* • 2.09 Clinical • 2.10 Generic substitution • 2.11 Adverse drug reporting • 2.12 Completing clinical trial applications * Also applicable to Vet. Medicines

35. MEDICINES A multisource (generic) productt A product line extension Biological medicine. NCE QUALITY EFFICACY SAFETY General information

36. TYPES OF APPLICATIONS 1. New chemical entity applications that include pre-clinical and clinical information 2. Multisource/generic applications and innovator product line extension applications that include clinical information in support of efficacy and safety of the formulation/dosage form, or indication/s or dosage regimen. 3.Multisource/generic applications and innovator line extension applications that include comparative bio-availability/bioequivalence studies as proof of efficacy. 4.Multisource/generic applications and innovator line extension applications that include comparative dissolution studies as proof of efficacy that include any other comparative studies as proof of efficacy others, not mentioned abovee.g. liquids/solutions. 5.Biological medicines

37. Expedited Review Process (Fast-track) • Speed up the registration process for specific medicines • Include, I)have important therapeutic benefit II)required urgently to deal with key health problems

38. Abbreviated Medicine Review Process (AMRP) • To limit the evaluation timeof pharmaceutical products(if the evaluation report is readily available) • Only new chemical entities registered with one or more of the authorities with which the Council aligns itself will qualify for AMRP • Based mainly on the expert reports of thePharmaco-toxicological and clinical data.

39. Include: • Expert Reviewers' reports • Certificate of approval of registration • Written confirmation that the proposed package insert is as per the complete dossier of the licensing country • Written confirmation that the data submitted to the MCC are identical to that submitted to the authority which has granted approval should be given • Relevant correspondence between the applicant and the registering authority

40. Expert Reports • An independent, objective and encompassing reportonall the relevant aspects in the specific field of expertise of the reporter who is familiar/acquainted with the development of the product. • All issues and properties areclearly identifiedand critically discussed . • Should address all the aspects in thepackage insert. • Thecurriculum vitaeof the expert should be included.

41. Licensing

42. Miscellaneous

43. Parallel Importation • This Act allows for the importation and registration of medicines which are under patent, are already registered in South Africa, and which originate from any site of manufacture approved by Council, regardless of any existing patent rights.

44. An e-submissions • Anexact replica of the hard copyversion. • Times New Roman, 12-point font • Black font colorwith a blue font used for hypertext links • The page orientation oflandscape pages • Page Size and Margins(A4 & 1.6 cm from all side) • Resolution of300 dots per inch (dpi)

45. File names up to32 charactersin length with a 3-character extension • For is ease of file navigation, the suggested format is a follows: (pt#)_(first six letters of the heading)_ (month and year) e.g. pt3_2a_pharma_0303.pdf • Electronic Signatures • Should beon a separate CD-R or DVD-R disk.

46. Veterinary Medicines

47. Efficacy Of And GCP For Veterinary Medicines • Recommendation to applicants wishing to conduct of clinical trials onveterinary medicinal products. • To ensure that those trials are conducted and documented in accordance with International Standards.

48. Licenses Issued

49. Notification of Registration of a Medicine

50. Press Statements