Vaccine Production and Regulation

Transcription

1 Vaccine Production and Regulation Dr Houda LANGAR Essential Vaccines and Biologicals Policy Department of Health Systems & Services Development Capacity Development Workshop on Health System Development Tehran, Islamic Republic of Iran, July 11-14, 2010

2 Introduction Important tool in disease prevention program A main technology input in health system Issues of availability of vaccines in the Region. Issues of accessibility to vaccines with assured quality and affordable prices especially for low middle and middle income countries. Potentials for vaccine selfsufficiency in EMR

3 WHO s Goal Assured quality for 100% of vaccines used in all national immunization program Definition of assured quality: ECBS and recommendations e o on safety, efficacy and quality in WHO TRS): National Regulatory Authority independent National Regulatory Authority functional, Non unresolved reported problem with vaccine *

4 Strategy to improve vaccine quality Strengthening the National Regulatory Authority in each country Priority 1: vaccine producing countries Priority 2: vaccine self-procuring countries Priority it 3: countries procured throughh UN agencies Improving the vaccine production to reach the prequalification status of the vaccines Ensuring a vaccine self-sufficiency production

5 Why an efficient National Regulatory Authority? Biologicals and complex products Vaccines used for prophylactic purposes on healthy population Ensure the quality, efficacy and safety of vaccines Knowing all kind of vaccines circulating in the country and all lots marketed Knowing the specifications of vaccines AEFI causality assessment 5

6 Role of NRA Ensure that vaccines released for use are evaluated properly and meet international standards: safety, efficacy and quality Covering a cycle starting from vaccine development until the administration of the vaccine as well as after immunizationi Define scientific documentation and criteria for licensing Issue, vary, suspend or withdraw licenses for vaccines on the basis of quality, safety and efficacy of vaccines 9

7 Role of NRA (Cont d) Continually oversee the quality of vaccines by releasing each lot intended for use in the country Monitor the impact of vaccines in use through a well functioning surveillance system for safety and quality Regulatory role in the procurement and management processes and practices of use Regular review of standardization and control of vaccines according to the current state of science and technology ;

8 Key elements for an efficient NRA Government commitment Legal basis National Policy/strategy for regulation and control Independence, competency, objectivity, impartiality, transparency & integrity Effective Quality Management System: organization, responsibilities, communication, long term vision and strategic plan, skilled & qualified human resources and sustainable financial resources, documentary system (quality manual, procedures, records), tools, monitoring and evaluation A

9 National Regulatory Functions Regulatory functions Regulatory system Marketing Authorization/Licensing Post marketing surveillance/aefi Lot release Laboratory access Regulatory inspections Authorization/Approval of CT & vaccine supply source UN agency Functions undertaken in producing countries Source of vaccines Procure Produce In countries that conduct clinical trials C

10 WHO Process to evaluate performance of regulatory system NRA Network of regulatory experts Benchmarking Planning to address gaps 5 day assessment GTN placement within 1-3 months months (6-8 months in needs much improvement) NRA assessment using tools Institutional Development Plan Training & Technical assistance Follow - up visit DE

11 What is WHO Prequalification? A service provided to UN purchasing agencies. Provide Independent opinion/ advice on the quality, safety and efficacy of vaccines for purchase Ensure that candidate vaccines are suitable for the target population and meet the needs of the programme Ensure continuing compliance with specifications and established standards of quality DD

12 Prequalification process Pre-requisite: Reliance on NRA Review of Product Summary File Testing of Consistency lots Consultation with NRA Evaluation of Clinical data Visit to manufacturing facilities Satisfactorily completed Vaccine pre-qualified: accepted for supply to UN agencies and posted on the Web list of WHO prequalified vaccines at

13 Why is it recommended to use WHO prequalified vaccines? ASSURED QUALITY: Effective and reliable NRA Evaluated by WHO Initial evaluation Regular reassessment Continuous monitoring by WHO D*

14 Vaccine production situation in EMR Few types of mainly traditional vaccines: EGY: TT, DT, dt, DTP, Cholera, Typhoid, IRA: PI (BCG- Hep B- Cholera & Typhoid); RAZI Institute (TT, DT, dt, DTP, Measles, Rubella, MMR, OPV, Rab) PAK: NIH (TT, Cholera, Typhoid, Rab), Amson Company (TT, Hep B, from bulk received from other manufactures) TUN: IPT (BCG) No WHO prequalified vaccines

15 Status of the Vaccine NRA in Iran ( ) 5 formal assessments in 1997, 2002, 2004, 2006 & 2010 and 6 follow-up visits in 1998, 1999, 2000,2005, 2007 & 2009 May 2010: NRA functional % 50 RS: regulatory system MA: marketing authorization PMS: post-marketing surveillance LR: lot release LA: laboratory access RI: regulatory inspection CT: clinical trials

16 Issues in the regulatory systems Governance issue: lack of policies, unclear or weak legal basis for authority, issue of independence Weak or limited quality management system: roles and responsibilities not well defined, lack of organization and communication, lack of long term vision and strategic plan, limited human and financial resources Misunderstanding of the regulatory system

17 Issues in vaccine production No GMP compliance Weak quality management system Weak or no process control in some critical steps of the production and the control No vaccine security and no vaccine selfsufficiency: vaccine supply, affordability of price, assured quality, response to emerging pandemic situation

18 Way Forward Mapping vaccine regulatory system in EMR countries WHO technical support for strengthening the NRAs Regional technical committee for evaluation of vaccines Regional network for lot release of vaccines Global network for Post-marketing surveillance: Iran, Tun Vaccine self-sufficiency (strengthening vaccine production, pooled vaccine procurement) DA

19 Thank you Essential Vaccines and Biologicals Policy Unit, World Health Organization, Eastern Mediterranean Regional Office, Abdul Razzak Al Sanhouri Street, P.O.Box 7608, Nasr City (11371), Cairo, Egypt