Seminar on… Medicines Control Council (MCC)

Seminar on…Seminar on…Medicines Control Council Medicines Control Council (MCC)(MCC)

Presented By: Mehul N. Padshala M.Pharm.

Department of Pharmaceutics and Pharmaceutical technology

L. M. College of Pharmacy

ContentContent

What is MCC?What is MCC?

Purpose and Purpose and Operates byOperates by

The structure of Council and its The structure of Council and its committeescommittees

Documents and GuidelinesDocuments and Guidelines

                                                                                                MCCStructure

 MRA Structure

 MRA Contact Details

                See below under Documents See below under Documents

Notification of registration of a medicine for February 2006AMENDMENT TO PHARMACEUTICAL AND ANALYTICAL GUIDELINE (Part 3)(See under Guidelines - Human medicines)Licenses issued until 25 November 2005Notification of registration of a medicine for November 2005Notification of registration of a medicine for September 2005Notification of registration of a medicine for July 2005UPDATED GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINES IN SOUTH AFRICA (See under Guidelines - Good Manufacturing Practices)EXEMPTIONS IN TERMS OF SECTION 36 OF ACT 101 - August 2005 (See under Exemptions in terms of Section 36 of Act 101) Notification of registration of a medicine for June 2005Notification of registration of a medicine for March and April 2005Safety update of Selective Serotonin Reuptake Inhibitors (SSRIS) (See under Communications to Industry)New safety information on the use of SSRIS in children under the age of 18 years. (See under Communications to Industry)Warning on hyperglycemia and diabetes mellitus with atypical antipsychotic agents (See under Communications to Industry)Proposed guideline on information of package inserts for human medicines (orthodox) (See under Communications to Industry)Notification of registration of a medicine for February 2005UPDATED GUIDELINE FOR STABILITY (See under Guidelines-Human medicines)TECHNICAL REPORT - ANTIMICROBIAL RESISTANCE CONGRESS (See under General Documents and Reports

What is MCC?

Medicines Control CouncilMedicines Control Council

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

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.

QUALITYQUALITY

SAFETYSAFETYEFFICACYEFFICACY

The Medicines Control Council applies applies standardsstandards laid down by the Medicines Medicines and Related Substances Control Act,and Related Substances Control Act, (Act 101 of 1965) which governs the manufacture, distribution, sale, and marketing of medicines.

The prescribing and dispensingprescribing and dispensing of medicines is controlled through the determination of schedules for various medicines and substances.

Operates 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.

Staff

Includes doctors, pharmacists, veterinarians, other scientists and administrative staff

 MCCMCCStructureStructure

 MRA Structure

 MRA Contact Details

                See below under Documents See below under Documents Notification of registration of a medicine for February 2006AMENDMENT TO PHARMACEUTICAL AND ANALYTICAL GUIDELINE (Part 3)(See under Guidelines - Human medicines)Licences issued until 25 November 2005Notification of registration of a medicine for November 2005Notification of registration of a medicine for September 2005Notification of registration of a medicine for July 2005UPDATED GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINES IN SOUTH AFRICA (See under Guidelines - Good Manufacturing Practices)EXEMPTIONS IN TERMS OF SECTION 36 OF ACT 101 - August 2005 (See under Exemptions in terms of Section 36 of Act 101) Notification of registration of a medicine for June 2005Notification of registration of a medicine for March and April 2005Safety update of Selective Serotonin Reuptake Inhibitors (SSRIS) (See under Communications to Industry)New safety information on the use of SSRIS in children under the age of 18 years.(See under Communications to Industry)Warning on hyperglycaemia and diabetes mellitus with atypical antipsychotic agents (See under Communications to Industry)Proposed guideline on information of package inserts for human medicines (orthodox) (See under Communications to Industry)Notification of registration of a medicine for February 2005UPDATED GUIDELINE FOR STABILITY (See under Guidelines-Human medicines)TECHNICAL REPORT - ANTIMICROBIAL RESISTANCE CONGRESS (See under General Documents and Reports

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C O M P L E M E N T A R Y M E D IC IN E S C O M M IT T E EC ha irpe rson

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V E T E R IN A R Y C LIN IC A L C O M M IT T E EC ha irpe rson

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A N A L Y T IC A L C O M M IT T E EC ha irpe rson

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C L IN IC A L C O M M IT T E EC ha irpe rson

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C L IN IC A L T R IA L S C O M M IT T E EC ha irpe rson

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P H A R M A C E U T IC A L / B IO A V A ILA B IL IT Y C O M M IT T E EC ha irpe rson

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P H A R M A C O V IG ILA N C E C O M M IT T EC ha irpe rson

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S C H E D U L IN G C O M M IT T E EC ha irpe rson

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M E D IC IN E S C O N T R O L C O U N C ILC ha irpe rson

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  MCC StructureMCC Structure :- :-

 MCCStructure

 MRA MRA StructureStructure

 MRA Contact Details

                See below under Documents See below under Documents

Notification of registration of a medicine for February 2006AMENDMENT TO PHARMACEUTICAL AND ANALYTICAL GUIDELINE (Part 3)(See under Guidelines - Human medicines)Licences issued until 25 November 2005Notification of registration of a medicine for November 2005Notification of registration of a medicine for September 2005Notification of registration of a medicine for July 2005UPDATED GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINES IN SOUTH AFRICA (See under Guidelines - Good Manufacturing Practices)EXEMPTIONS IN TERMS OF SECTION 36 OF ACT 101 - August 2005 (See under Exemptions in terms of Section 36 of Act 101) Notification of registration of a medicine for June 2005Notification of registration of a medicine for March and April 2005Safety update of Selective Serotonin Reuptake Inhibitors (SSRIS) (See under Communications to Industry)New safety information on the use of SSRIS in children under the age of 18 years.(See under Communications to Industry)Warning on hyperglycaemia and diabetes mellitus with atypical antipsychotic agents (See under Communications to Industry)Proposed guideline on information of package inserts for human medicines (orthodox) (See under Communications to Industry)Notification of registration of a medicine for February 2005UPDATED GUIDELINE FOR STABILITY (See under Guidelines-Human medicines)TECHNICAL REPORT - ANTIMICROBIAL RESISTANCE CONGRESS (See under General Documents and Reports

Medicines Regulatory Medicines Regulatory Affairs:-Affairs:-

M ed ic in es R egu la to ry Affa irs O rg an og ram

F in an ce

C D C C

D irec to ra teO p era tio ns & A d m in istra tion

In sp e ctora teD e pu ty D irec to r

L a w E nfo rce m e ntD e pu ty D irec to r

D irec to ra teIn spe cto ra te & La w E nfo rce m e nt

C lin ica l Un it

C lin ica l T ria ls

D irec to ra teC lin ica l E va lua tio n & T ria ls

P ha rm a ce utica l & A n a ly tica lP re-Re g is tra tionD e pu ty D irec to r

P ha rm a ce utica l & A n a ly tica lP o st-Re g is tra tionD e pu ty D irec to r

D irec to ra teM ed icin e E va lua tio n & R ese arch

C lus te r: M e d ic in es Re gu la to ry A ffa irsR e g is tra r o f M ed icin es

DocumentsDocumentsActs 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

Acts and RegulationsActs and Regulations

Medicines and related Medicines and related substances control act 101 of substances control act 101 of 19651965

Same like a D & C ActD & C Act, India

To provide the all all information related to the information related to the registrationregistration of medicines and related substances intended for human and for animal use.

Regulation of Act 101Regulation of Act 101Therapeutic equivalenceInternational Tendering ProcessingParticulars to be published in the gazette Labelling , Package inserts and Patient information

leafletPrescription bookImport and ExportLicensingRegistrationARD, Price controllingVeterinary Medicines Advertising of Medicines

SCHEDULES TO ACT 90SCHEDULES TO ACT 90

Classified the drugs in a SEVEN schedules

Schedule: Schedule: Any Schedule 0,1 substance

may be sold in an open shop

Schedule 2, Schedule 3 or Schedule 4 substance

may be repeated if the person who issued the prescription has indicated (NMT 6 times )

Schedule 5 substance

shall not be prescribed for longer than six months

Schedule 6 substance

it shall not be repeated without a new prescription being issued

Communications to industry

ADR Terminology Used In ADR Terminology Used In Package InsertsPackage Inserts

According to System Organ Classes

FrequencFrequencyy

Very common >1/10

Common >1/100, <1/10

Uncommon >1/1,000, <1/100

Rare >1/10,000, <1/1,000

Very rare <1/10,000

DHCP-letterDHCP-letter

A Dear Health Care ProfessionalA Dear Health Care Professional also referred to as a Dear Doctor Dear Doctor letterletter

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.

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

Fees payable to the Registrar Fees payable to the Registrar

CategorCategoryy

CategoryCategory AA

Human medicine Human medicine including including biologicalsbiologicals

Ready to useReady to use

CategoryCategory CCVeterinary Veterinary medicines, medicines, including including

biologicalsbiologicals CategoryCategory BB

Human medicine Human medicine including including biologicalsbiologicals

Req. Req. ManipulationManipulation

FormsForms

Document and ReportsDocument and Reports

GMPGMP

Why needed??Why needed??Facilitate the removal of barriersthe removal of barriers to trade in medicinal products, to promote uniformity in licensing promote uniformity in licensing decisionsdecisions and to ensure the maintaining of high maintaining of high standards of qualitystandards 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)Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Pharmaceutical Inspection Co-operation Scheme (PIC/S)Scheme (PIC/S)

Medicines Control Council of South Africa Medicines Control Council of South Africa accepts the European, British or United States Pharmacopoeia.

CHAPTER

TITLE

11 Quality Management

2 2 Personnel

33 Premises And Equipment

4 4 Documentation

55 Production

66 Quality Control

77 Contract Manufacture And Analysis

88 Complaints And Product Recall

99 Self-inspection

AnnAnnexex

TitleTitle

1 Manufacture of sterile medicinal products

2 Manufacture of biological medicinal products for human use

3 Manufacture of radiopharmaceuticals

4 Manufacture of veterinary medicinal products other than immunologicals

5 Manufacture of immunological veterinary medical products

6 Manufacture of medicinal gases

7 Manufacture of herbal medicinal products

8 Sampling of starting and packaging materials

AnnAnnexex

TitleTitle

99 Manufacture of liquids, creams and ointments

1010 Manufacture of pressurised metered dose aerosol preparations for inhalation

1111 Computerised systems

1212 Use of ionising radiation in the manufacture of medicinal products

1313 Manufacture of investigational medicinal products

1414 Manufacture of products derived from human blood or human plasma

1515 Qualification and validation

Annex Title

16 Organisation and Personnel

17 Parametric release

18 GMP Guide for active pharmaceutical ingredients

Parametric ReleaseA 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.

Human MedicinesHuman Medicines

HUMAN MEDICINES2.01 General information2.02 Pharmaceutical and analytical2.03 Alcohol content of medicines*2.04 Post-importation testing*2.05 Stability *2.06 Biostudies2.07 Dissolution*2.08 Post registration amendments*2.09 Clinical2.10 Generic substitution2.11 Adverse drug reporting2.12 Completing clinical trial applications

* Also applicable to Also applicable to Vet. MedicinesVet. Medicines

General informationMEDICINE

S

NCE A

multisource (generic) productt

A product

line extensio

n

Biological medicine.

QUALITY

SAFETY

EFFICACY

TYPES OF APPLICATIONSTYPES OF APPLICATIONS11. New chemical entityNew chemical entity applications that include pre-pre-clinical and clinical informationclinical and clinical information

22. Multisource/generic applicationsMultisource/generic applications and innovator innovator product line extension applicationsproduct line extension applications that include clinical information in supportclinical information in support of efficacy and safety of the formulation/dosage form, or indication/s or dosage regimen.

33. Multisource/generic applicationsMultisource/generic applications and innovator line extension applications that include comparative bio-comparative bio-availability/bioequivalence studiesavailability/bioequivalence studies as proof of efficacy.

4.4. Multisource/generic Multisource/generic applications and innovator line extension applications

that include comparative dissolution studiescomparative dissolution studies as proof of efficacy

that include any other comparative studiesany other comparative studies as proof of efficacy

others, not mentioned abovenot mentioned above e.g. liquids/solutions.

5.5. Biological medicinesBiological medicines

Expedited Review ProcessExpedited Review Process (Fast-track) (Fast-track)

Speed up the registration process for specific medicines

Include, I) have important therapeutic have important therapeutic benefitbenefit

II) required urgently to deal required urgently to deal with key with key

health problemshealth problems

Abbreviated Medicine Abbreviated Medicine Review Process (AMRP)Review Process (AMRP)

To limit the evaluation timeTo limit the evaluation time of pharmaceutical products (if the evaluation report is readily available)

Only new chemical entitiesOnly 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.Pharmaco-toxicological and clinical data.

Include: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 countryWritten 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

Expert ReportsExpert Reports An independent, objective and independent, objective and encompassing reportencompassing 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 identifiedclearly identified and critically discussedcritically discussed .Should address all the aspects in the package package insert.insert. The curriculum vitaecurriculum vitae of the expert should be included..

LicensingLicensing

MiscellaneousMiscellaneous

Parallel Parallel ImportationImportation

This Act allows for the importation and importation and registrationregistration of medicines which are medicines which are under patent, are already under patent, are already registeredregistered in South Africa, and which which originate from any site of originate from any site of manufacture approvedmanufacture approved by Council, regardless of any existing patent regardless of any existing patent rights. rights.

An An ee-submissions-submissions

An exact replica of the hard copyexact replica of the hard copy version.

Times New RomanTimes New Roman, 1212-point font

Black font colorBlack font color with a blue font used for hypertext links The page orientation of landscape pageslandscape pages Page Size and Margins (A4 & 1.6 cm from A4 & 1.6 cm from all sideall side)Resolution of 300 dots per inch (dpi)300 dots per inch (dpi)

File names up to 32 characters32 characters in 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)_ (pt#)_(first six letters of the heading)_ (month and year)(month and year)

e.g. pt3_2a_pharma_0303.pdfe.g. pt3_2a_pharma_0303.pdf

Electronic SignaturesElectronic Signatures

Should be on a separate CD-R or DVD-R on a separate CD-R or DVD-R diskdisk.

Veterinary MedicinesVeterinary Medicines

Efficacy Of And GCP For Efficacy Of And GCP For Veterinary MedicinesVeterinary Medicines

Recommendation to applicants wishing to conduct of clinical trials on veterinary medicinal productsveterinary medicinal products.

To ensure that those trials are conducted and documentedconducted and documented in accordance with International accordance with International Standards.Standards.

Licenses IssuedLicenses Issued

Notification of Registration Notification of Registration of a Medicineof a Medicine

Press StatementsPress Statements

Log on to Log on to

www.mccza.www.mccza.comcom

Reference

Study Questions:Study Questions:

Give the structure of MCC and Give the structure of MCC and MRA.MRA.

Discuss in brief:Discuss in brief:•DHCP letterDHCP letter•Fast TrackFast Track•AMRPAMRP•Parallel importationParallel importation•e- Submission to MCCe- Submission to MCC