Mohamed Abdelhakim Essential Medicines and Health Technologies Team

1. WHO Prequalification Programme of Medicines: Experience Working with Manufacturers and Regulators in the WHO Eastern Mediterranean Region Mohamed Abdelhakim Essential Medicines and Health Technologies Team World Health Organization – Regional Office for the Eastern Mediterranean WHO-EMRO Amman, June 2013

2. Background: • Started in 2008 and became more systematic in 2010 through the continuing support of PQP • Low level of awareness and interest among regulatory authorities from the region (access focus rather than quality) • Low level of interest among manufacturers (cost concerned less interest in accessing institutional and stringent markets)

3. Activities- Focused on three pillars: 1- Advocacy and outreach: • Mapping of manufacturers with potential from the region and establishing contact with them • Researching • Meetings both inter country and in country: Egypt in 2008 and UAE in 2010 for GCC manufacturers • National workshops in Iran, Pakistan, Syria and Egypt • Presentations in regional and national forums were regulators and manufacturers attend • Sometimes teleconference or video conference with manufacturers • Producing some advocacy material (posters, communiques, briefs , etc…)

4. 2- Technical Assistance: • One manufacturer in Pakistan on development of CTD dossier (TA received in 2011 submitted in 2013) 3-Capacity Building and training : Trying to add value and to train innovatively I- CTD dossier assessment training in Amman and Casablanca in 2011: • 6 manufacturers from Saudi, Jordan, Iran, UAE and Egypt.2 manufacturers participated partially (Pakistan and Morocco ) • Regulators from the same countries (Dossier assessors and GMP inspectors) II- GMP inspection training in Salalah, Oman: Mock inspection: included: HVAC, Water System, Cleaning and process validation .Another GMP inspection training is planned towards the end of the year.

5. Work with manufacturers for the past 6 years resulted in: • Increase in the number of dossiers submitted from the region and accepted for assessment from zero in 2008 to 7until May 2013 and more than 15 products expected for submission in 2014-2015

7. Experience working with Regulatory Authorities in the Eastern Mediterranean Region • More than 100 regulators trained on international standards in dossier assessment, GMP inspection compliance and Bioequivalence studies • The programme is positively perceived by regulators from all countries in the region – it assists in filling the NMRA’s chronic gap of less resources allocated for training regulatory human resources • Several regulators reported back on conducting the training or some parts of it when they go back to their agencies as a knowledge transfer method • Some inspectors joined PQP inspection missions in the region as observers and reported it as a wonderful experience

8. Experience working with Manufacturers in the region • Experience working closely with manufacturers indicated that first priority of Manufacturer from the region when enrolling in the programme was not to achieve short term or quick financial gains but rather: • Image improvement by being listed as a WHO Supplier for one of their products (positive externality) • Improving technical standard • Facilitated Access to stringent markets (ICH) • Receiving technical assistance by WHO

9. Cont’d • Now more companies are interested in the new WHO - NMRA collaborative mechanism on Fast track registration of prequalified products • Higher interest and success rate in acceptance among Manufacturers already exporting to or aiming to access regulated markets (ICH) • Dossiers submitted sometimes not following the guidelines for development of the quality part of the dossier resulting in an increased duration for screening and assessment results • Turnover affects continuity of plans: In some manufacturers PQP champions are there and if they leave the programme leaves with them

10. Challenges and bottlenecks to manufacturers from the region API source and data • Complex Starting Material (SM)- lower cost API yes but not accepted by PQP • API producers may negotiate the closed part versus price increase Bioequivalence study (GCP/GLP compliance) • Very few in the region have received inspections from Stringent Regulatory Authorities (SRA’s) and thus not too many options which affects cost – technical assistance in this area is needed by the programme GMP compliance • Several major observations and less on critical observations • Again very few exporting to stringent markets and hence not used to inspections from SRA’s • Companies which passed Saudi FDA inspection showed better results

11. Conclusion: • WHO PQP is a main player in bringing the wave of international standards in quality, safety and efficacy of medicines to the region • The programme is working in parallel with both Regulators and Manufacturers to implement internationals standards in medicines regulation and manufacturing • PQP standards are attainable by companies if: • A vision to work ahead of time is adopted by senior management • Allocating some staff time to the programme can be instrumental in accelerating the process • Quality comes at a cost so minor to moderate investment in majority of companies currently involved in the process has been a common factor (BE mainly)

12. Thanks for your attention abdelhakimm@who.int