REGULATORY CHALLENGES IN SOUTH AFRICA

Transcription

1 REGULATORY CHALLENGES IN SOUTH AFRICA MEDICINES CONTROL COUNCIL SA Prof Peter Eagles Chairperson Medicines Control Council [Southern African Regional and International Symposium (SARI 2014)] 1

2 OUTLINE Introduction Policy Framework Legislative Framework Pillars of Medicine Regulation Operations and Processes Regulatory Challenges Closure 2

3 INTRODUCTION ELEMENTS OF EFFECTIVE MEDICINE REGULATION: WHO, 1999 Regulation and control of medicines is not an option but an imperative for national health programs Necessary policy objectives and the legislative provisions Decisions should be based on scientific evidence and facts Practicable enforcement capacity Accountability and public interest/public good Safeguard against conflict of interest 3

4 INTRODUCTION cont ELEMENTS OF EFFECTIVE MEDICINE REGULATION: WHO, 1999 Good regulatory practice and standards adequate and appropriate: Human Financial Technical Physical resources supported by appropriate SOPs and policy guidelines Regulation is based on risk 4

5 ELEMENTS AT MCC ELEMENTS OF EFFECTIVE MEDICINE REGULATION: MCC, 2014 Policy objectives: National Drug Policy Department of Health Strategic Plan (vision, mission) Legislative provision: Medicines and Related Substances Act, 1965 (Act 101/1965) [amended 17 times] Human Resources MCC & Expert Committee s (9 Committees) MRA staff (150 staff members) 5

6 ELEMENTS AT MCC cont Financial Resources Department of Health Budget (MRA) Department of Health Budget (MCC) Collection of Fees R30millon per annum (payable to Treasury) Policy guidelines Total number : 47 SOPs and Flow diagrams Directorates within MRA 6

7 Vision POLICY FRAMEWORK Department of Health (To have) an accessible, caring and high quality health system Mission To improve health status through prevention of illness and the promotion of healthy lifestyles and to consistently improve the healthcare delivery system by focusing on access, equity, efficiency, quality and sustainability 7

8 POLICY FRAMEWORK cont National Drug Policy Adequate and reliable supply of safe, costeffective medicines of adequate quality to all citizens Availability and accessibility of Essential Medicines to all in the country Quality, Safety and Efficacy of medicines through evaluation, testing, registration and postregistration variation and surveillance (All must obey) Good Dispensing and Prescribing Practices Rational use of medicines Individuals should be responsibility for health, 8 preventive care and informed decision making

9 LEGISLATIVE FRAMEWORK The regulation and control of medicines in South Africa is governed by the Medicines and Related Substances Act (Act 101 of 1956), and the Regulations to that Act The Act establishes the Medicines Control Council (MCC), a statutory body as a juristic person 9

10 LEGISLATIVE FRAMEWORK cont The Act also provides for the following: The powers, functions and operations of the MCC (company board??) Regulation and registration of medicines intended for human and animal use Control of the manufacture, storage, and distribution of medicines and Scheduled Substances 10

11 LEGISLATIVE FRAMEWORK cont Measures for the supply of more affordable medicines in certain circumstances Licensing of certain persons to compound, dispense or manufacture medicines, or to act as wholesalers or distributors Appeals against decisions of Director-General of Health Medicines Control Council 11

12 PILLARS OF MEDICINE REGULATION Existence of an Independent Medicine Regulatory Authority the MCC Separation of powers, Transparency & accountability 12

13 PILLARS OF MEDICINE REGULATION cont Registration of Medicines: Quality, Efficacy, Safety Control Aspects: Who may manufacture, distribute, prescribe, dispense, import, export, etc Compliance with requirements: Reporting of Adverse Reactions Medicine recalls etc 13

14 PILLARS OF MEDICINE REGULATION cont Inspection and Law Enforcement Sanctions and Penalties Information that may be published Confidentiality Clause (Information for health professionals and for consumers) Control of Promotion, Advertising and Ethical Conduct Prohibitions, Exemptions and Special Approval 14

15 TECHNICAL REQUIREMENTS Clinical safety and efficacy Quality of Innovator and Generic medicines (including veterinary and biological medicines) Good Manufacturing Practices (GMP) Good Clinical Practices (GCP) Good Wholesaling and Distribution Practices (GWP) 15

16 OPERATIONS AND PROCESSES Evaluation of applications for registration of medicines for amendment of registered medicines Market Surveillance and Pharmacovigilance Monitoring: Importation and Exportation Control border posts 16

17 OPERATIONS AND PROCESSES Evaluation and approval of Clinical Trials and Bioequivalence Protocols Licensing of Manufacturers Wholesalers (we have)administrative and Technical support of Council and its Committees Dissemination of medicines regulatory information 17

18 OPERATIONS AND PROCESSES cont Processing of fees and claims Conducting of inspections GMP GWP GCP Investigation of illegal sale of medicines 18

19 CHALLENGES IN SOUTH AFRICA 19

20 ENSURING THE QUALITY OF APIs Quality of Active Pharmaceutical Ingredients (API) The recent EU legislation which reformed the rules of importing APIs for medicinal use has forced the MCC to: Initiate tighter oversight of APIs by implementing GMPs for API s Inspect API manufacturers in RSA Share intelligence with other medicine authorities on API quality manufactured in RSA 20

21 REGULATORY COLLABORATION AND NETWORKING The MCC is faced with increased workload and limited resources MCC has embraced international regulatory collaboration Membership of PIC/S to allow for sharing of GMP inspection reports Observer status at EDQM Joining International Generic taskforce Sharing intelligence on product quality, safety by issuing of Alert notifications Pilot ectd applications 21

22 PHARMACOVIGILANCE AWARENESS Increasing concerns of the safety of medicines has led to MCC advancing its pharmacovigilance systems and strengthening its capacity Increased monitoring of the product life-cycle Organizational initiative to establish a Pharmacovigilance Inspection subunit Perform PharmacoVigilance inspections 22

23 PHARMACOVIGILANCE AWARENESS cont In addition MCC focus on increased lifecycle pharmacovigilance by Developing data standards and guidelines Surveillance of signals At National level and International level from other Regulatory Authorities 23

24 REGULATION OF BLOOD & BLOOD PRODUCTS The WHA resolution (2010) emphasized need for regulatory authorities to assure quality, safety and availability of blood for transfusion MCC has initiated training on GMP for Blood Establishments Measures are being put in place to commence regulatory oversight of Blood Establishments 24

25 REGULATION OF HERBAL MEDICINES Word-wide the regulatory authorities are putting measures in place to assure regulatory oversight of Herbal medicines to ensure quality and safety Publication of Regulations on 15 Nov 2013 to address regulatory oversight of Herbal / Complementary medicines The MCC developed guidelines on the registration of Herbal / Complementary medicine 25

26 REGULATION OF MEDICAL DEVICES World-wide the regulatory authorities are putting measures in place to assure regulatory oversight of Medical Devices and IVDs to ensure safety, quality and (good)performance Legislation to address the regulatory oversight of Medical Devices and IVDs is under review by the DoH and MCC The MCC is considering best practices for the regulatory oversight as prescribed by the Global Harmonization Task Force 26

27 CLOSURE CHALLENGES REGULATORY AUTHORITY Majority of the challenges relate to aspects of: Human Financial Physical resources Challenges have been acknowledged by Minister and Department of Health and the following actions are being developed Establishment of SAHPRA (imminent) an)organization within the (broader) public administration BUT outside the public service 27

28 END MCC WEBSITE: The Registrar of Medicines Private Bag X828 PRETORIA 0001 Tel: Fax: