1. Workshop on Medicines Regulation in the Caribbean Barbados, September 8-9, 2009 Essential Regulatory Functions: Quality Assurance The CRDTL Experience Lucette Cargill Caribbean Regional Drug Testing Laboratory

2. Essential Regulatory Functions Licensing of premises, practices and persons Inspection of manufacturers and distributors Product assessment and registration Monitoring quality of drugs Control of drug promotion and advertising Adverse drug reaction monitoring

3. Monitoring Drug Quality When  Pre-registration  Post-marketing Why  Verify quality attributes before registration  Verify quality of procured products  Verify quality of products in circulation  Investigate complaints or other problems

4. Establishment of the CRDTL The Caribbean Regional Drug Testing Laboratory was established to provide the region with a well-equipped quality control laboratory to evaluate the quality of pharmaceuticals used in the region. This would enable the selection of drugs of good quality for use by identifying those of reliable quality. Work commenced in 1980.

5. Testing Activities The laboratory has operated a routine surveillance programme built largely around a priority list of drugs selected by the Technical Advisory Committee. Submissions for pre-registration or pre- tender analysis, routine surveillance, quality problems or other regulatory actions etc. also received

6. Users of Services The main users of the laboratory are Drug Regulatory Authorities, and the OECS- PPS. Other users include pharmaceutical manufacturers, distributors and occasionally, hospitals.

7. Submissions to the CRDTL Country/ Agency 2004-20052005-20062006-20072007-20082008-2009 Barbados2632354534 Belize2349 Dominica211 Guyana1337893815 Haiti12 Jamaica809566289178 OECS PPS76641082030 Trinidad & Tobago 837463624

8. Products analyzed the CRDTL Country/ Agency 2004-20052005-20062006-20072007-20082008-2009 Barbados2625323634 Belize9818 Dominica1111 Guyana1524865115 Haiti12 Jamaica6910575142164 OECS PPS85511132630 Trinidad & Tobago 922412238

9. Reasons for submissions of products YearRoutinePre-registration Pre-Tender Product in Development InvestigationOther 2004- 2005 15744763 2005- 2006 14573984 2006- 2007 25983142 2007- 2008 1471308114 2008- 2009 100178025

10. Percentage of Products Out of Specification YearRoutinePre-registration Pre-Tender Product in Development InvestigationOther 2004- 2005 8257170 2005- 2006 10322250 2006- 2007 1150750 2007- 2008 1716124525 2008- 2009 169500

11. Performance on Selected Tests Test 2004-20052005-20062006-20072007-20082008-2009 Assay186 (7%)146 (6%)329 (5%)253 (6%)241 (2%) Disintegration4338 (3%)41 (3%)25 (8%)13 (8%) Dissolution110 (5%)103 (9%)234 (6%)194 (14%)192 (12%) Identification14698239 (1%)224224 (<1%) Sterility406752 (2%)3972 (4%) Uniformity120112 (6%)250 (2%)199 (4%)171 (<1%)

12. Challenges Unavailability of product monographs  Usual sources are United States, British and International Pharmacopoeia  Monographs not included for some products  Drug Regulatory Agency should provide manufacturer’s monograph submitted with application for registration  Some countries do not have registration systems in place

13. Challenges Unavailability of reference Standards  Normally purchased from USP, BP, WHO Collaborating Centre  Some standards not available from these sources  Reference substances generally supplied to regulatory agency with registration application  Some countries do not have registration systems in place

14. Challenges Scheduling issues  No control over timing of submissions  No prior knowledge of planned activities of user agencies Equipment issues  Unavailability of infrequently used item Resources

15. Possible Solutions Collaboration with national laboratories  Laboratory network?  Other mechanisms? Cooperation of regulatory agencies  Harmonized registration requirements  Regional approach  Provision of reference standards  Agreement on specifications for pharmaceutical preparations

16. Thank You