GCC Regulatory MAA & post approval requirements (Saudi Arabia & UAE) unit-5 RADC (RA)

GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration process (SA), Drug Registration Requirement (SA), Post Registration Requirements in (SA), Drug registration regulations UAE Medicinal Product Registration process (UAE), Drug Registration Requirement (UAE).
Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products.
SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products.
The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
SFDA prefers the drug dossier submission in electronic format (eCTD).
It is an independent authority from the Ministry of Health.
Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees.
Upload the eCTD file to the system through the SDR system portal. 
A soft copy of the eCTD should be submitted labelled as per the SFDA guideline, along with the hard copies of the original documents.
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people.

1. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE Presented by: Vanshika Gupta MRA201T (RADC) 2nd sem M.Pharm (RA) PARUL INSTITUTE OF PHARMACY 1 GULF COOPERATION COUNCIL SAUDI ARAABIA AND UAE

2. CONTENTS GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 2 GCC countries Drug registration regulations of Saudi Arabia Medicinal Product Registration process (SA) Drug Registration Requirement (SA) Post Registration Requirements in (SA ) Drug registration regulations UAE Medicinal Product Registration process (UAE) Drug Registration Requirement (UAE )

3. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 3 The emirate of the riyadh province The emirate of the makkah province The emirate of the eastern province The emirate of the madinah province The emirate of the al baha province The emirate of the al jawf province The emirate of the northern borders province The emirate of the qassim province The emirate of the ha'il province The emirate of the tabuk province The emirate of the ' aseer province The emirate of the jizan province The emirate of the najran province Saudi Arabia states Saudi Food and Drug Authority (SFDA) 

4. Gulf Cooperation Council (GCC) GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 4 Cooperation Council for the Arab States of the Gulf

5. DRUG REGISTRATION REGULATIONS OF THE KINGDOM OF SAUDI ARABIA GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 5 Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products. SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products. The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products. SFDA prefers the drug dossier submission in electronic format (eCTD). It is an independent authority from the Ministry of Health. Drug Registration Regulations of Saudi Arabia

6. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 6 Medicinal Product Registration process (SA):

7. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 7 Medicinal Product Registration process (SA): Conti...

8. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 8 Market Authorization The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases: Phase 1 Step 1: Online Registration on the Drug Establishments National Registry (DENR) The applicant register online on the DENR to get a  username and password , which enables the applicant to log in and avail all the electronic services of the drug sector. Step 2: Marketing Authorization Application (MAA) Submission: The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees. Upload the eCTD file to the system through the SDR system portal.  A soft copy of the eCTD should be submitted labelled as per the SFDA guideline , along with the hard copies of the original documents. MAA Medicinal Product Registration (SA)

9. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 9 Phase 2 Step 1: Validation The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement . Step 2 - Assessment, Testing and Inspection The relevant departments will evaluate the MAA to assess quality, safety, and efficacy , along with the onsite GMP inspection and sample analysis by the SFDA central laboratories. Step 3 - Pricing The Pricing Department will review the product’s price according to the “SFDA's pricing rules.” Step 4 - Product Licensing The Registration Committee will review the registration request for approval. MAA Medicinal Product Registration (SA) Conti...

10. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 10 B) Verification and Abridged Procedure Verification Process This process will be applicable if the product has been approved and marketed by both the European Medicines Agency ( EMA ) and the United States Food and Drug Administration ( USFDA ). Abridged Process This process will be applicable if the product has been approved and marketed by either the EMA or the US FDA. C) Waiver of Onsite GMP Inspection Onsite GMP inspection can be waived if the manufacturing facility is approved by the Gulf Cooperation Council – Drug Registration MAA Medicinal Product Registration (SA) Conti...

11. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 11 D) Importance of Local Entity for a Foreign Manufacturer For any foreign medicinal product manufacturer, it is mandatory to have an authorized representative in Saudi Arabia for administrative support and for Regulatory communication with the SFDA. E) Importation of Non-Registered Product SFDA allows the importation of non-registered products for the cases mentioned below: Essential drugs Drugs for which substitutes are not available in the Saudi market MAA Medicinal Product Registration (SA) Conti...

12. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 12 Format: eCTD recommended. Module 2 to 5: according to ICH CTD format. Module 1: Regional requirements: Cover letter Table of contents ( ToC ) Application form Product information: summary of product characteristics ( SmPC ), product information leaflet ( PIL ) and labeling – all in WHO template format. Information on experts involved in clinical, nonclinical studies Environment risk assessment. Pharmacovigilance Certificate of pharmaceutical product ( CoPP ) Pricing Response to questions asked by SFDA (in any) Drug registration requirements in Saudi Arabia

13. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 13 Module 2: Common Technical Document Summaries Table of Contents of Module 2-5. Introduction: (Section including pharmacologic class , mode of action, and proposed clinical use of pharmaceuticals) Quality Overall Summary: (The whole section is required and should reflects the information provided in Module 3) Non- Clinical Overall Summary: Clinical Overview: Biopharmaceutics , bioequivalence/bioavailability study reports should be provided Drug registration requirements in (SA) Conti..

14. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 14 Module 3: Quality The whole section is required and the information should be presented CMC data Module 4: Non-Clinical Study Reports • Generally not applicable for generic products Module 5: Clinical Study Reports Table of contents for Module 5 Tabular listing of all clinical studies Clinical study reports Literature Reference Drug registration requirements in (SA) Conti...

15. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 15 Certificates Following Certificates required: CoPP / free sale certificate CoA Pork-free declaration Price list Drug registration requirements in (SA) Conti...

16. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 16 Any changes on a registered product (includes the change in name of a marketing authorization holder, change in name of API, deletion of manufacturing site, batch size change, change in a manufacturing process, change in control of API, primary container closure system, shelf life, etc) has to be submitted to the SFDA as a Variation of MAA. Minor variations Type IA: Minor variations do not require prior approval before implementation. Type IA variations should be submitted within 14 days . Type IB: Minor variations that must be submitted to the SFDA by MAH before implementation, but do not require a formal approval. The MAH must wait a period of 60 working days to ensure that the application is deemed acceptable by the SFDA before implementing the change. Major variations Type II: Major variations in which there might be a significant impact on the Quality, Safety or Efficacy of a pharmaceutical product and require prior approval before implementation. Post Approval requirements in Saudi Arabia & UAE

17. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 17 SFDA recommends the GCC guidelines for stability study data preparation. Stability data requirement (SA & UAE) Active Pharmaceutical Ingredient Finished Pharmaceutical Product Stress testing Selection of batches Selection of batches Container closure system Container closure system Specification Specification Testing frequency Testing frequency Storage conditions Storage conditions Stability commitment Stability commitment Evaluation Evaluation Statements and labeling Statements and labeling In-use stability testing Ongoing stability studies Variations Ongoing stability studies

18. GCC United Arab Emirates

19. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 19 Emirates of the United Arab Emirates ​Dubai Health Authority (DHA) follows the Ministry of Health and Prevention (MOHAP) 

20. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 20 For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention ( MOHAP ) in the United Arab Emirates. The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people living here. The approval process for drugs in Saudi Arabia is similar to many other countries. The drug manufacturer submit application to the SFDA, which includes data from clinical trials, information about the manufacturing process, and other relevant data. The SFDA reviews application requires additional information before making decision. DRUG REGISTRATION REGULATIONS UAE

21. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 21 Process of Pharmaceutical Product Registration UAE:

22. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 22 Process of Pharmaceutical Product Registration UAE: Conti...

23. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 23 Administrative information Distributor of product in UAE Manufacturing site Marketing authorization holder and power of attorney Manufacturer of API Regulatory status Price list Declaration Product dossier Drug product information Packaging patient information leaflet Labeling Storage condition and shelf-life Composition Ingredients of animal origin Leaflet information Pharmacological properties Bioequivalence details for generic product Drug registration requirements in UAE

24. GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 24 Certificate of the product or certificate of free sales issued by the competent authority in the country of origin The certificate should contain the product brand name and formulation of the product containing active and inactive substances. Name and address of the company that has the right to marketing/ manufacturing Information on the product’s shelf life and storage conditions Confirmation that product is marketed in country of origin for at least two years Three Samples of the product Copy of internal leaflet certified by competent authorities in the country of origin Certificate of Product analysis of the samples Halal certificate issued by certified authorities and organizations Requirements for Registration in UAE

25. References GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 25 Pateriya S, Janodia M, Deshpande P, Ligade V, Talole K, Kulshrestha T, et al. Regulatory aspects of pharmaceuticals’ exports in gulf coopération council countries. J Young Pharm [Internet]. 2011;3(2):155–62. Available from: https://www.jyoungpharm.org/sites/default/files/10.4103-0975-1483.80305.pdf Dgra.de. [cited 2023 May 18]. Available from: https://www.dgra.de/media/pdf/studium/masterthesis/master_el-malahi_zohaira_2018.pdf Medicinal product registration in Saudi Arabia, KSA, SFDA [Internet]. Freyrsolutions.com. [cited 2023 May 18]. Available from: https://saudiarabia.freyrsolutions.com/medicinal-products-regulatory-support-in-saudi-arabia

26. References GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 26 Gov.sa. [cited 2023 May 18]. Available from: https://www.sfda.gov.sa/sites/default/files/2022-08/The_GCC_Guidelines_0.pdf Regulatory requirements for drug approval in Saudi Arabia [Internet]. Slideshare.net. [cited 2023 May 18]. Available from: https://www.slideshare.net/Sridhars83/regulatory-requirements-for-drug-approval-in-saudi-arabia-95472248 View of overview of post approval changes requirements for active pharmaceutical ingredients in Canada, Australia and Saudi Arabia [Internet]. Jpionline.org. [cited 2023 May 18]. Available from: https://www.jpionline.org/index.php/ijpi/article/view/1173/615

27. References GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 27 Procedures for pharmaceutical registration in UAE [Internet]. Fotis . Fotislaw ; 2022 [cited 2023 May 18]. Available from: https://fotislaw.com/lawtify/registration-of-pharmaceuticals-in-uae/ Gov.sa. [cited 2023 May 18]. Available from: https://www.sfda.gov.sa/sites/default/files/2021-10/RegulatoryFramework_1.pdf Gov.sa. [cited 2023 May 19]. Available from: https://www.sfda.gov.sa/sites/default/files/202210/GuidanceSubmissionV5_0.pdf

28. References GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 28 What you should know about SFDA classification and Drug registration [Internet]. Cosmotrace.com. [cited 2023 May 19]. Available from: https://blog.cosmotrace.com/serialization/what-you-should-know-about-sfda-classification-and-drug-registration Property JI. Register pharmaceutical products with UAE Ministry of Health? [Internet]. Jitendra Intellectual Property. 2020 [cited 2023 May 18]. Available from: https://jcatrademarkuae.com/how-to-register-pharmaceutical-products-with-uae-ministry-of-health/

29. Thank you