Registration Insights & Pricing Structure Across The MENA Region. Mr Yahya A. Al jefri. CEO, Annahdah Medical Company, Saudi

Transcription

1 1 Registration Insights & Pricing Structure Across The MENA Region Mr Yahya A. Al jefri. CEO, Annahdah Medical Company, Saudi

2 AMC company profile 2

3 AMC establishment 3 Established in 1971, AMC is considered to be one of the top ten Saudi companies in its domain. Founded as a family business by Mr. Abdullah Al-Jefri, Chairman of the BOD, former Passport & Nationality General Manager, former Mayor of Jeddah.

4 Mr. Yahya Al Jefri (VP, CEO) 4 MBA, King A/Aziz University- Jeddah VP of Pharmaceuticals Committee Jeddah Chamber of Commerce (JCC). International trainer in strategic planning & management.

5 46 years AMC milestones Closed Share Holding Company 2012 The Highest Growing Company In Pharma Saudi Market (31%) 2005 Restructure & Pharmaceutical Focus 1971 AMC Establishment

6 Head office in Jeddah 7 4 branches through KSA West Cente r South East

7 Sales dep. structure 8 Sales department Promotion Team: 5 line managers. 14 supervisors. 56 medical reps. Sales Team: 4 Branch sales managers. 20 Sales reps.

8 Marketing dep. structure 9 Marketing department 4 product managers: 1 for Pharmaceutical ranges. 1 for Food Supp. ranges. 2 for Medicated Cosm. ranges.

9 Governmental sales dep. 10 structure Regional sales manager (West & South) 2 Gov. sales reps Regional sales manager (Center & East) 2 Gov. sales reps Follow up by: MR per line

10 Distribution Fleet refrigerated vehicles covering the cities and the remote areas KSA

11 Annahdah customer categories 12 Governmental Sector Military Sector MOH and GCC NUPCO Indep. centers

12 Annahdah customer categories 13 Private Sector Polyclini cs Private Hospital s Pharmaci es (chain & street) Wholesalers

13 14 Partners Business models Agency & distribution Marketing, agency & distribution

14 AMC partnerships across the 15 world & expanding

15 16 14 Agency & dist. partners

16 17 Marketing, agency & dist. partners Pharma: 17

17 18 Marketing, agency & dist. partners Medicated cosmetics: 18

18 19 17 Marketing, agency & dist. partners Food supplements:

19 Services for partners 20 Regulatory Activities: Manufacturing Facility GMP Certification, registration & renewal. Product Registration & pricing. Distribution, Sales & Marketing in Private and Governmental sectors. Post Marketing analysis.

20 21 Registration Insights & Pricing Structure Across The MENA Region Mr Yahya A. Al jefri. CEO, Annahdah Medical Company, Saudi

21 Topics 22 - Requirements for introducing medical products into MENA region: 1- Bioequivalence study. 2- Stability study. 3- Raw material API. 4- Minimum batches. 5- Analysis. 6- Site registration. 7- Reference countries. 8- Pricing. - MENA region registration time intervals & fees.

22 Bioequivalence study 23 BE centers should be approved by the country s authorities. GCC requirements: - In general, 24 healthy non smoking volunteers, years, within 15% range of ideal BMI. - Special requirements for specific products. Required for: Exclusions: - Products with systemic effects. - Syrups, IV injections & aqu. IM injections. - Dosage forms without systemic effects; creams, supp. & sprays. - Immediate release tablets (based on

23 Stability study 24 Some countries require an approved laboratory. GCC States are categorized in climatic zones III & IVa. General case: - Long-term: 30 C ± 2 C/ 65% RH± 5% / 12 months. - Accelerated: 40 C ± 2 C/ 75% RH± 5% / 6 months. Refrigerated products: - Long-term: 5 C ± 3 C. / 12 months. - Accelerated: 30 C± 2 C/ 65% RH± 5% / 6 m. Frozen products: - Long-term: -20 C ± 5 C / 12 months.

24 Raw materials 25 (API) certificate from supplier for active ingredient. Certificate of suitability. Complete DMF (Drug Master file) & letter of access to it. GCC needs a clarification letter: - No alcohol content. - Pork free ingredients. - For soft gel capsules; certif. of suitability about the source. - In some cases: Halal certificate. In some MENA countries; commitment letter that the source is not from a country of conflict.

25 Minimum batches 26 Matching with ICH guidelines (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). GCC: 3 different batches.

26 Analysis 27 Certificate of analysis for FP (Finished Product). Certificate of analysis for reference standard. No. of samples according to the country authority guidelines. Analysis in MOH lab or from a specified list (Lebanon).

27 Site registration 28 General requirements: - SMF (Site Master File). - Valid & legalized GMP. - Valid & legalized ML (Manufacturing License). - List of countries where the site is registered. - List of the products produced by the manufacturer. A must in most MENA countries. Not needed in some countries like Algeria & Libya; factory chart & documentation are included in product reg. files.

28 References countries 29 In which the product must be registered before starting registration in the targeted country. KSA: the product should be registered & marketed in COO (country of origin). Lebanon: 2 references. Iraq: 2 references. Oman, Qatar & Bahrain: to be registered in GCC.

29 File submission 30 Online filling of the application form. Drug submission file includes: Application form +product file + drug sample. Submissions are classified mainly as: Drugs, food supplement, cosmetics, medical device & health products. Fees payment. A scheduled appointment (long queue in some countries).

30 Registration Box 31 Some countries have quota of reg. products per AI; - UAE & Lebanon: Egypt: 5 products. - KSA: Not specified. Some countries have national list for protected products produced within the country like Algeria (will be cancelled after WTO treaty).

31 Pricing 32 Required data for GCC & SFDA: - CIF price. - Ex-Factory price. - Wholesaler price in COO. - Public price in COO. - Price certificate form (form 30).

32 Registration time & fees 33 Country Type Body Inspection KSA Manuf. Products SFDA or GCC GCC Inspection CTD or ectd ectd (pharma) CTD (herbal & health) Fees $ /Pharma. File subm.: 2,700 Audit visit: Acc. to site location as below Biological & brand: 25,000 Generics: 10,500 Herbal & Health: 5,300 Fees $ /Cosm. NA Fees $ /MD 4,000 6,000 acc. to class Inspection fees per region: Gulf, Levante & Egypt = 16,000$. N. Africa = 23,000$. Europe & Turkey = 32,000$. N. & S. America = 43,000$ China = 27,000$. Japan = 39,000$ Australia = 49,000$. Reg. time Biological & brand: 290 WD Generics: 165 WD Herbal & Health: 155 WD MD: 35 WD

33 Registration time & fees 34 Country Type Body Inspection CTD or ectd Fees $ /Pharma. Fees $ /Cosm. Fees $ /MD Reg. time UAE Manuf. Ministry of Health 350 GCC Drug Control CTD Inspection Department Products months Kuwait Manuf. 995 Ministry of Health GCC CTD Drug and Food Control inspection Products 331 NA NA 7 11 months Oman Manuf. Ministry of Health. 259 GCC Medicines Regulatory e CTD inspection Authority. Products months

34 Registration time & fees 35 Country Type Body Inspection Bahrain CTD or ectd Fees $ /Pharma. Manuf. 100 National Health GCC CTD Regulatory Authority inspection Products 146 Fees $ /Cosm. Fees $ /MD Reg. time (months) NA NA 6 9 Qatar Manuf. Products Supreme Council of Health GCC inspection CTD No fees NA NA 7 11 Yemen Iraq Iran Manuf. 200 Ministry Of Health No inspection Normal Products 250 Manuf. 1,711 Ministry of Health No inspection Index Products 855 Manuf. NA National Drug Inspection CTD Selection Council Products NA NA NA

35 Registration time & fees 36 Country Type Body Inspection CTD or ectd Fees $ /Pharma. Fees $ /Cosm. Fees $ /MD Reg. time (months) Palestine Manuf. Ministry of Health. 1,000 General Directorate of No inspection Index Pharmacy. Products Jordan Manuf. Line/1000 Jordan Food & Drug Inspection CTD Administration Products Lebanon Manuf. Ministry of Public Health No inspection e CTD Depend on inspection cost NA NA 9-13 Products 3,150

36 Registration time & fees 7 Country Type Body Inspection Egypt CTD or ectd Manuf. Ministry of Health and Inspection Index Population Products 500 Fees $ Fees $ Fees $ Reg. time /Pharma. /Cosm. /MD (months) Depend on inspection cost Morocco Algeria Tunis Libya Sudan Manuf. Not required Ministry of Health No inspection CTD Products 1,476 Laboratoire National de Contrôle Des Produits Pharmac., ministère de la Santé Manuf. Not required No inspection CTD Products 435 Manufactu rer Ministère de la Santé 1,200 products Direction de la Pharmacie No inspection Index et du Medicament 1,131 Manufactu National Transitional 150 rer Council No inspection Index products Ministry Of Health 150 Manuf. 800 National Medicines and No inspection CTD Poisons Board Products 350 NA NA NA NA NA

37 38 Price structure; Pharmaceutical products KSA: Retail price = CIF price + 10% wholesaler markup + 15% pharmacy markup. (1 st generic is 65% or less from the originator for KSA & gulf). Oman: Retail price = 1.55 times of CIF price (including wholesaler margin of 22%). Jordan: Retail price = CIF + 3% customs + 10% clearance + 0.7% transportation + 15% agent markup + 21% Pharmacy markup.

38 39 Price structure; Pharmaceutical products Palestine: Retail price = CIF + 7 % -13% customs & clearance + 23% distribution + 24% pharmacy markup. Iraq: Retail price = CIF % marketing % distribution % pharmacy markup (Customs & clearance can be avoided). (1 st generic is 50% or less from the originator). Libya: Retail price = CIF price % expenses (Taxes - Shipping - Customs) + 35 % wholesaler margin (marketing expenses to be added) + 40 % pharmacy margin. Sudan:

39 Price structure; Food 40 supplements KSA: Herbal products are freely priced. Minerals are freely priced below a specified concentration. Vitamins are priced. UAE, Oman & Yemen: Retail price = CIF price * 3.2. Jordan, Palestine, Lebanon & Mauritania: Retail price = CIF price * 2.4.

40 In brief 41 BE center should be approved Raw materials (alcohol & pork free) ectd & CTD files Stability study for zone III & IVa Site registration (pre-audit recommended) Fees, pricing & time / country Need for well experienced & knowledgeable agent

41 42 Thank you

42 Contact us 43 Web site: E. Mail: Tel: ext. 103 Fax:

43 MENA Market Size f 2017f 2018f 2019f 2020f Pharma sales $bn % of GDP f = BMI forecast. Source: World Health Organization, BMI

44 MENA MARKET 45 SEGMENTATIONS Pharma market sales Levant 15% GCC 50% North Africa 35%