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medicines control council


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Seminar on…Medicines Control Council (MCC) : 

Seminar on…Medicines Control Council (MCC) Presented by: Naitik Thakkar M. Pharm-II 1/49

Inclusions : 

Inclusions What is MCC? Purpose and Operated by The structure of Council and its committees Documents and Guidelines Study Questions Reference 2/49

What is MCC? : 

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. 3/49

History : 

History So far, more than 20 000 medicines have been approved. Since the establishment of the Medicines Control Council, more than 220 meetings have been held to decide on the registration of medicines. Applications for more than 11 800 complementary medicines have been submitted for evaluation by the Complementary Medicines Committee. The South African Pharmacy Council has licensed 300 wholesalers and distributors. These must still be licensed by the Medicines Control Council in terms of the Medicines Act. The Medicines Control Council approves more than 280 clinical trials annually. 4/49

Purpose : 

Purpose 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. 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. 5/49

Operated by: : 

Operated by: External experts who are members of Council Committee structures. The office of the Registrar provides administrative and technical support. The Registrar is also an executive secretary to 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. 6/49

MCC Structure : 

MCC Structure 7/49

MRA Structure : 

MRA Structure 8/49

Documents : 

Documents Acts and Regulations Communications to industry Exemptions in terms of Section 36 of Act 101 Fees payable to the Registrar Forms General Documents and Reports Guidelines - Good Manufacturing Practices Guidelines - Human Medicines Guidelines - Licensing Guidelines - Miscellaneous Guidelines - Veterinary Medicines Index to Guidelines and Forms Licenses Issued Notification of Registration of a Medicine Press Statements 9/49

Acts and Regulations : 

Acts and Regulations 10/49

Medicines and related substances control act 101 of 1965 : 

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. 11/49

Regulation of act 101 : 

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 12/49

Schedules to act 90 : 

Schedules to act 90 Classified the drugs in a SEVEN schedules 13/49

Communications to industry : 

Communications to industry 14/49

ADR Terminology Used In Package Inserts : 

ADR Terminology Used In Package Inserts According to System Organ Classes: 15/49

DHCP-letter : 

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. 16/49

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Contains any safety information about a medicine. Must be submitted to the MCC for review. The Pharmacovigilance Committee will present all approvals of DHCP letters as part of its report to Council. 17/49

Fees payable to the Registrar : 

Fees payable to the Registrar 18/49

Fees payable to registrar : 

Fees payable to registrar Mainly 3 category: Category A: Human medicines including biologicals (Ready to use) Category B: Human medicines including biologicals (Required manipulation) Category C: Veterinary medicines including biologicals 19/49

Forms : 

Forms 20/49

Documents and Reports : 

Documents and Reports 21/49

GMP : 

GMP 22/49

Why needed????? : 

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. 23/49

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Human Medicines : 

Human Medicines 28/49

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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 Bio-studies 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 Veterinary Medicines 29/49

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The aim of these Guidelines is to assist applicants in the preparation of documentation for the registration of medicines for human use. The types of medicine include A new medicine for a new chemical entity (NCE), A multisource (generic) product, A product line extension, and A biological medicine. 30/49

Expedited Review Process (Fast-track) : 

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 31/49

Abbreviated Medicine Review Process (AMRP) : 

Abbreviated Medicine Review Process (AMRP) To limit the evaluation time of 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 the Pharmaco-toxicological and clinical data. 32/49

Expert Reports : 

Expert Reports An independent, objective and encompassing report on all 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 are clearly identified and critically discussed. Should address all the aspects in the package insert. The curriculum vitae of the expert should be included. 33/49

Licensing : 

Licensing 34/49

Miscellaneous : 

Miscellaneous 35/49

Recalls : 

Recalls Recall - means the removal of specific batch/batches of a medicinal product from the market for reasons relating to deficiencies in the quality, safety or efficacy. Withdrawal - means the total withdrawal of a medicinal product from the market. 36/49


CLASSIFICATION OF RECALLS Recalls are classified into both the class according to the level of health hazard involved (risk to the patient) and Type which denotes the depth or extent to which the product should be recalled from the distribution chain, e.g. Class I, Type C recall, etc. 37/49

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Class I Class I is for defective/dangerous/potentially life-threatening medicines that predictably or probably could result into serious health risk/adverse events or even death. Class II Class II is for medicines that possibly could cause temporary or medically reversible adverse health problem or mistreatment. Class III Class III is for medicines that are defective and are unlikely to cause any adverse health reaction. 38/49

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Type A Action: Recall letter to all distribution points plus media release. Type B Action: Recall letter to all distribution points. Type C Action: Specific telephone calls, recall letters to/representatives calling at distribution points if known where the medicines have been distributed. 39/49

Veterinary Medicines : 

Veterinary Medicines 40/49

Notification of Registration of a Medicine : 

Notification of Registration of a Medicine 41/49

Press Statements : 

Press Statements 42/49

Links : 

Links 43/49

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Indian Pharma in African Market : 

Indian Pharma in African Market Zydus Cadila Torrent Pharmaceuticals Dr. Reddy’s Labs Ranbaxy Pharmaceuticals Intas Pharmaceuticals Sun Pharmaceuticals 45/49

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MCC approved CRO’s in Ahmedabad Accutest BioArc Research Labs Zydus Research Center (ZRC) Torrent Research Center (TRC) Cadila Pharma Lambda Research Center Veeda Research Center Synchron Research Labs 46/49

Study Questions: : 

Study Questions: Give the structure of MCC and MRA. Discuss in brief: DHCP letter Fast Track AMRP e- Submission to MCC 47/49


REFERENCE: Log on to : 48/49

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Thanks to All

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