15th Jeddah Marketing Club (Regulatory Insights & Pricing in KSA) by dr. Ahmed Abdel Aziz *#Mahmoud_Bahgat* *#Marketing_Club* للاشتراك في نادي التسويق بالشرق الاوسط *If you are a Marketer now* To Join our whatsapp &Monthly Meeting in Middle East Cities Send me ur data on Whatsap 00966569654916 *Fill ur data here as speaker or member* https://lnkd.in/efkTE7T Join now *Marketing Club Facebook Page* https://lnkd.in/gm4c4hD *Marketing Club Facebook Group* https://lnkd.in/gX-5au5 *Egyptian Pharmacists Society Facebook Page* https://lnkd.in/fucnv_5 ••••••••••••••••••••••••••••• *#Mahmoud_Bahgat* 00966568654916 لخدمات التسويق والدعاية والاعلان *#Legendary_ADLAND* Complete Marketing Solutions *www.TheLegendary.info* ••••••••••••••••••••••••••••• للحصول على اقامة او شركة في اوروبا *#Legendary_Europe* Europe Companies & Residency *www.LegendaryEurope.Net* ••••••••••••••••••••••••••••• *Contact Bahgat* M.Bahgat@TheLegendary.Info

1. Registration Insights & Pricing Structure in KSA
Dr. Ahmed Abdel Aziz
Business development
& Marketing manager
Ducray,Aderma , Pierre Fabre
AnnahdahMedicalcompany,KSA
Marketing Club Instructor

3. Registration Insights
& Pricing Structure in KSA

4. Introduction
Ahmed Abdel Aziz yousef
Background
 MBA Eslsca Paris
 BSc pharmacy
Experience
 10 years experience in pharmaceutical market
Current Position
Acting Business development & Marketing manager
Ducray, Aderma , Pierre Fabre
Annahdah Medical company, KSA

5. Goals & topics to cover
Significance of KSA pharma market
Highinternational standards of SFDA
Basicrequirements of SFDA, its duration & fees
Whywe need to know about regulatory requirements
Basicintroduction to business development
Regulations maybe difficult, but not impossible

6. Why we need to know about regulatory
requirements ?
1- you are going to work
in Business Development !
2- you are entrepreneur !
3- you are marketer & need to
understand the opposite side !

7. stake holders in supply chain
Marketing
Business
Development
Regulatory
Marketing
Business
Development
Regulatory

8. Basic function of business development in
operating units
Business Development objective is to improve the organization
market position & achieve financial growth.
 Main role is to identify strategic opportunities , Products or Partners
Identify evaluate Deal

9. Significance of KSA pharma
markets
9

10. MENA region
• MENA region: NA, Levante & GCC.

11. Gulf Cooperation Council
(GCC) countries
• GCC includes
Saudi Arabia, United Arab Emirates, Bahrain,
Kuwait, Qatar & Oman.

12. Pharma market size in GCC
countries
12
2015 2016 2017
Pharma sales $bn 9.8 9.9 10.3
Growth% (in value) -3% 1% 3.4%
% of GDP ≈1.2%
Approximateestimations, based on WHO, IMS and CIA fact book.

13. Contribution of the GCC within the MENA
region pharma market
Levant
15%
North
Africa
35%
GCC
50%
The contribution of
the GCC within the
MENA region pharma
market is relatively
mobile, but can be
estimatedas 50%.
13
Approximateestimations, based on WHO and CIA fact book.

14. Contribution of the KSA within the GCC
pharma market
Approximateestimations, based on WHO and CIA fact book.
KSAcontributes with
about 60% from total
GCC pharma market
sales.

15. Basic requirements for medical
products for KSA
15

16. Basic requirements for medical
products for KSA
Points to cover:
1- Bioequivalence study.
2- Stability study.
3- Raw material API.
4- Minimum batches.
5- Analysis.
6- Site registration.
7- Reference countries.
8- Pricing.
9- Registration time & fees.

17. Bioequivalence study
• BE centers should be approved by the country’s authorities (SFDA).
• Requirements:
- In general, 24 healthy non smoking volunteers, 18 – 55 years,
within 15% range of ideal BMI.
- Special requirements for specific products.
• Required for:
- Products with systemic effects.
 Exclusions:
- Syrups, IV injections & aqueous IM
injections.
- Dosage forms without systemic effects;
creams, supp. & sprays.
- Immediate release tablets (based on Bio
pharmaceutics Classification System).

18. Stability study
• 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.
(A commitment should be made to continue the stability
studies post-approval in order to firmly establish the shelf-life.).

19. Raw materials
• (API) certificate from supplier for active ingredient.
• Certificate of suitability.
• Complete DMF (Drug Master file) & letter of access to it.
 SFDA needs a clarification letter:
- No alcohol content.
- Pork free ingredients.
- For soft gel capsules; certif. of
suitability about the source.
 Commitmentletter that the source is not from
a country of conflict.

20. Batches
• Matching with ICH guidelines (International Conference
on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use).
• SFDA: 3 different batches.
20

21. Analysis
• Certificate of analysis for FP (Finished Product).
• Certificate of analysis for reference standard.
• No. of samples, according to SFDA guidelines, is for ex.:
– 20 ampoules 1 – 2 ml.
– 15 ampoules 2 – 5 ml.
– 200 capsules.
– 15 bottles of oral syrup / suspension.
– 20 – 30 bottles of drops, according to size.
– 20 tubes of ointments & creams.

22. Site registration
• A must in KSA.
• 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.
22

23. References countries
• In which the product must be registered before starting
registration in the targeted country.
• For SFDA, the reference countries are USA, Canada, Germany,
Italy, France & Japan.
• For SFDA, the product should be registered & marketed in
COO (country of origin).
23

24. File submission
• Online submission of New products through SFDA/GCC new
Submission System (Gateway)
• Drug submission file in the form of eCTD file.
• Submissions are classified mainly as:
New Drugs and Biologicals, Generic Drugs, Herbal & Health products,
food supplement, cosmetics & medical device.
• Fees payment.
• A scheduled appointment
( no need for appointment for new Registration
(new submission system)
24

25. Pricing
• Required data for GCC & SFDA:
- CIF price.
- Ex-Factory price.
- Wholesaler price in COO.
- Public price in COO.
- Price certificate form
(form 30).
- Pricing in reference countries
as included in the price form
25

26. Registration time & fees
Country Type Body Inspection
CTD or
eCTD
Fees $ /Pharma.
Fees $
/Cosm.
Fees $
/MD
Reg.time
KSA
Manuf.
SFDAor GCC Inspection*
eCTD
(pharma)
CTD
(herbal&
health)
File subm.:
2,700
Auditvisit:Acc.
to site location
as below
NA
NA
Biological
& brand:
290 WD
Generics:
165 WD
Herbal&
Health:
155 WD
MD:
35 WD
Products
Biological&
brand:
≃ 33550 + 5%
VAT
Generics:
≃ 13330 + 5%
VAT
Herbal& Health:
≃ 6400 + 5%
VAT
4,000
to
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$.

27. Price structure; Pharmaceutical products
• KSA:
Retail price = CIF price + 10% wholesaler markup + 15%
pharmacy markup.
Originator price is reduced by 20% after patency expiry &
registering first generic.
1st generic is 65% or less from the originator for KSA & gulf.
2nd generic less by 10% from first generic, etc., till the fourth
generic.

28. Price structure; Food supplements
• KSA:
Herbal products are freely priced.
Minerals are freely priced below a specified
concentration.
Vitamins are priced.
28

29. Regulations need to be studied,
understood& applied
29
GCC
ww.gcc-sg.org
SFDA
www.sfda.gov.sa

30. Thank You!

31. 15th Jeddah MarketingClub Wednesday 31-10-2018