Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Assessment of Medicines Regulatory Authorities (MRAs) WHO, Geneva, Switzerland 18 november 2009 Alain PRAT, Technical adviser, MRS/TCM/HSS WHO - Geneva Plan of the session The assessment process The process approach The content of the assessment tool Some figures and outcomes 2| Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Why an assessment tool ? In line with one of the strategic objectives – To strengthen National Regulatory Authority's capacities To assess in order to to identify strengths and weaknesses To make recommendations on identified gaps for improvement To propose/suggest supporting activities to satisfy the identified needs To use assessment results as a tool for convincing decisionmakers to obtain more support; 3| Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Main steps of the assesssment / 1 Expression of a need – Internal / External – Scope of the assessment – Objectives and expected outcomes Assessment team – Qualification, experience, availability – Minimun 2 – Staff from the organization assessed Preparation works – – – – – 4| Request baseline information Study of available information Validation of the scope covered Preparation of the assessment plan Validation of the plan with the institution Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Main steps of the assessment / 2 Opening session – Presentation of assessment team, objectives, methodology – Presentation of the authority Conducting the visit – Follow planned activities, – Collection of evidence Closing session – Presentation of the main findings and related recommendations – Presentation of the institutional plan – Closing remarks Follow up – Provide for the draft report, collect the comments and finalize – Initiate/consider supportive actions 5| Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Mapping the regulatory actors Regulatory functions Related actors / Institutions Manufacturers, distribution channel licensing MoH Registration NRA Regulatory Inspections Inspectorate Quality control laboratory NQCL Safety monitoring of marketed products National Vigilance center Clinical trial Institutional Review Boards Control of drug promotion Drug Information Center 6| Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Mapping the processes / Historical findings based on 21 assessments Marketing authorization Licencing Regulatory Inspection Quality Control Pharm.Vigilance Number of MRA = 21 7| 1 2 Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva 2 4 1 6 2 3 Assessment methodology Not based on impressions, feelings or any subjective considerations Based on objective evidence Evidence collected through interviews should, whenever possible, be confirmed by more objective means Possible deficiencies or gaps should be thoroughly investigated and validated Consensus should be reached at the end with auditees 8| Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Documented evidence Interviewing personnel Reviewing manuals, guidelines developped Studying records Reading reports Scanning files or applications Analyzing data, indicators Observing activities performed and facilities where they are performed Examining conditions during these activities 9| Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Documented evidence Investigations not only to check the presence or the absence of a document (law) But to pursue to find the evidence on the implementation And ideally the evidence that it provides the desire results….. Examples : – Law has been issued and Regulation is missing – Law and regulation are published but no guidance is provided to applicants – Administratives procedures are established but no records are demonstrating its implementation – Administratives decisions are published but without any legal framework 10 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Mapping the processes / 1 Ressources are input for the process – Results are the outputs of the process Outputs from the process N – are inputs for the process N+1 Structures/ Inputs Processes Outcomes are very often difficult to assess 11 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Outputs Outcomes Mapping the processes / 2 Manage vision, mission, strategies, policies Manage the ressources needed : human and others Manage the relation with patient and customers Manage the production of products and/or services Manage supporting activities Manage continuous improvement 12 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva MRA is a process in itself Control Drug Promotion Quality Control Product Information Marketing authorization Regulatory Inspection Pharmaco vigilance Few business processes 13 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Import Control Licensing Recent improvement for the tool Chapter on clinical trial developed Chapter on vigilance aspects developed New chapter on Narcotics New chapter on International cooperation Quality management system for NRAs No more open question All chapters reviewed and design consolidated 14 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Design of the assessment tool Same format for each modules / functions – – – – – – – 15 | Legal basis, framework Guideline and Documentation Organisation and structure Planning and internal procedures Human and other Ressources Records and others outputs Availability of these information Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Chapters of the tool 16 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Institutional structure / 1 Legal basis Governance structure Organization in place Quality management system Funding Management of human resources 17 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Institutional structure / 2 Independence and impartiality Transparency and confidentiality Management of committees and external expertise Infrastructure and equipment Monitoring and accountability IT Management 18 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Marketing Authorization Qualified personal Equipments and facilities maintained Pertinent guideline SOP implemented Adequate legal framework Reception Records Evaluation Pre-Market Inspection Tests Comittee Planing and monitoring Application 19 | Assessment process Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Decision MA + Ann. Examples of key findings and gaps (Inspections) / 1 Regulation – No regulations for compliance with good manufacturing practices (GMP) and good distribution practices (GDP) Guideline – The available GMP guidelines are not updated to comply with WHO guidelines. – There are no Good Distribution, Storage or Wholesaling Practice Guidelines – Written official GMP guidelines do not exist at the moment except the unfinished draft – There is no official National GMP guideline and the WHO GMP guidelines have not been officially adopted, although they are being used 20 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Examples of key findings and gaps (Inspections) / 2 Human resources – Lack of competency in GMP auditing – Limited human resources in GMP and GDP activities – Some of the staff have received limited but not adequate training in GMP inspection. They also lack experience. – There is no legal officer in the department. – The number and skills of inspectors is not adequate, considering the number of manufacturers to be inspected. Independence/Impartiality – No code of conduct for inspectors – No provision or guidelines regarding conflict of interest of inspectors exist 21 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Examples of key findings and gaps (Inspections) / 3 QMS and SOP – No periodicity defined for performing inspection and inadequate duration of inspection – No quality management system for inspectorate and in particular no documented procedure for documentation control, no internal periodic review or auditing – Documented procedure for planning, preparation, inspection and follow up not finalized – No procedure for qualification as inspector and inspection team leader – ProcedureS for follow up of deficiencies identified during inspections do not exist. – Written checklist and plans for inspection of manufacturers and distribution channels are not available. 22 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Examples of key findings and gaps (Inspections) / 4 Equipment / IT – Limited access to the internet – Inadequate logistical support i.e. communication tools on the field, vehicles and computers Organisation – Poor communication with the regional inspectors – No coordination or collaboration or exchange of information on inspection activities – No mechanism to demonstrate that all inspectors in the country follow the same procedure Records and outcomes – No consolidated list of inspection activities performed 23 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Usefulness of indicators Marketing Authorization – – – – Number of application received, Number of MA delivered . Time to acknoledge receipt of application ; Time to deliver a MA ; Time/delay to publish MA with related Product Information. Inspection – Number of inspection – Time between two inspections ; – Time between initial inspection and follow up inspections (in case of non compliance) 24 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva List of institutions to be visited and Personnel to be met / 1 Ministry of Health / Ministry of industry, Representatives of the Regulatory authority and any other organizations involved in the regulatory functions, Staff of Regulatory authority or organization, Representatives of the Industry Association of manufacturers, distributors, importers and exporters, Representatives of the Professional Association of general practitioners, nurses and pharmacist, Professionals councils (medical practitioners council, pharmacists council) 25 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva List of institutions to be visited and Personnel to be met / 2 Representatives of Consumers' associations, Journalists. Non-governmental associations Procurement agencies, National medicines stores Health research organizations Chairmen or representatives of Advisory committee Chairmen or representative of IRB / IEC Representative of university academician 26 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Main source of documented evidence / 1 Regulatory authority – – – – – – – – – – – – 27 | Act, Law, Decree or circular establishing the Regulatory authority Corporate, strategic and business plan of the NRA Mission, vision, objectives and indicators of the NRA, i Quality manual, List of Internal procedure List of internal forms and templates List of the fees applicable for licensing, registration or authorization Organigram/organization charts Code of conduct/code of ethics List of staff with their qualification List of external experts Annual report, self-assessment report Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Main source of documented evidence / 2 Regulatory functions (Registration, Licensing, Inspection, Clinical Trail, Pharmaco-vigilance, Market control, Import Control, Quality Control Laboratory, control of drug promotion – Act, Law, Decree or circular establishing legal provisions for each regulatory functions – Guidance published on this domain – Internal procedure – List of equipment – Job descriptions – Decision, Authorization and their annexes 28 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Issuance of Recommandations Based on the various life cycles of the activities needed such as : – – – – – – – – 29 | To convince politicians To change laws or decrees To develop a guidance with consultative process To reorganise and reshape the structure (centralized/decentralized activities) To implement QMS, to develop procedures and planning To manage HR To change records To implement communication strategy Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Guidance to use this tool Regulatory assessment process – – – – For each regulatory function – – – – – Brief narrative description of the function List of questions Quantitative indicators of activities, of performances Documented evidence to be reviewed (plan, procedures, reports, job descriptions, etc) References to be consulted, based on WHO bibliography Annexes – 30 | Main steps of a Regulatory assessment Different categories of assessment in the time Duration General advice about assessment Templates Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva MRA assessments worldwide 44 Assessments performed on 40 Regulatory systems (with the involvement of HQ) – – – – – – AFRO - 21 COUNTRIES / 24 ASSESSMENTS EURO - 2 COUNTRIES / 2 ASSESSMENTS EMRO - 4 COUNTRIES / 5 ASSESSMENTS SEARO - 4 COUNTRIES / 4 ASSESSMENTS WPRO - 7 COUNTRIES / 7 ASSESSMENTS PAHO - 2 COUNTRIES / 2 ASSESSMENTS WHO Regional assessments – ???? Self-assessments – ??? 31 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva MRA assessments in AFRO region 2008 2007 2006 2004 2003 2003 No 32 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva AFRO : Outcomes / Few examples Publication of the main drug law 8 7 6 5 4 3 2 1 0 Before 1979-1988 1989-1998 1999-2003 2004-2008 1979 33 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva AFRO : Outcomes / Few examples Various kinds of MRAs 5 3 34 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva 13 MoH Board Agency AFRO : Outcomes / Few examples Committees within the marketing authorization processes 6 Committee in place Committee not functional 11 4 35 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva No committee AFRO : Outcomes / Few examples GMP requirements Not required (42%) Not in line with WHO (24%) 36 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva Not published (29%) In line with WHO (5%) Thanks for your attention 37 | Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva