SFDA Pharmaceutical

&
Medical Device Regulations
Pharmaceutical Regulations
 ENTRY PROCEDURE IN SAUDI ARABIA
• Appointment of exclusive distributor
• Distributorship agreement
• Registration of agreement in Ministry of
Commerce
• Two possible routes of registration:
– GCC Executive Board and/or
– SFDA
 REGISTRATION MODES
• Gulf Cooperation Council (GCC) Countries central
registration
– Facilitates registration in all GCC countries i.e. KSA, Kuwait,
U.A.E, Qatar, Bahrain, Oman and Yemen
– Participation in annual GCC tender for pharmaceuticals.
– After GCC registration SFDA registration is required for
selling in Non GCC tender sectors

• Saudi Food & Drug Authority (SFDA) Registration

– Allows to sell in non GCC tender sector. Participation in
Saudi Arabia local tenders and local purchase order
business
 GCC REGISTRATION
(Manufacturing Facility)
• Submission of files
– Product registration
– Manufacturing facility registration

• GMP inspection of manufacturing facility

– Timing with mutual arrangement
– Inspection of upto 2 manufacturing lines in one visit
– A team of 2-3 inspectors from GCC countries visit.
– Manufacturing lines for registration should be operating.
– CAPA after the visit.
– Serious observations may require another visit.
– Approval for 5 years.
– In case of rejection new application can be made after 1 year.
 GCC REGISTRATION
(Manufacturing Facility)
• Within one year from GCC registration, local
registration in each GCC country is required by
completing administrative procedure.

• If an application is not made within a year, the

manufacturer has to follow local registration
requirement, whenever the apply for
registration.
 GCC REGISTRATION
(Product)
• Dossier to be in eCTD format.
• Approval of dossier.
• Finished product lab analysis in GCC reference lab (KSA
or UAE or Kuwait).
• Fixation of unified CIF price in USD for GCC countries.
• Issuance of GCC registration certificate and certified
copies for each member country.
• Submission of copy of registration dossier along with
certified copy to obtain local product registration
number in each country.
• Apply for retail price fixation in each member country.
 GCC REGISTRATION
(Dossier Requirements)
• ECTD format.
• ICH guidelines
• Stability studies to be according to GCC stability
guidelines i.e. Zone IV
• Approved center for Bioequivalence studies:
– Approved by any of the 2 authorities during last 5
years (USFDA, Health Canada, TGA, MHRA & EMA).
– If not requires GCC approval.
• Approval of brand name & storage conditions in
Arabic language.
 GCC REGISTRATION
(Product Selection Critical steps)
• Product to be manufactured on the approved
manufacturing line.
• Registered and marketed in countries with
advanced regulatory authorities. (Preferable)
• Registered and marketed in country of origin for
at least 1 year.
• Possibility of getting a viable registered price.
• COS approved raw material. Otherwise open part
of DMF with dossier and Letter of Access from
API manufacturer for the closed part is to be
submitted.
 SFDA REGISTRATION
• If manufacturing facility & product is approved
in GCC only copies of dossiers are submitted
along with certified copy of GCC certificate to
obtain local registration.
• If company wants to register only in Saudi
Arabia, they can directly apply in SFDA.
• The procedure more or less same as in GCC.
 SFDA REGISTRATION
(Retail Price Approval)
• SFDA considers the following parameters to fix
price of a generic product:
– Registered price in country of origin
– Registered price in 30 reference countries
– Reference price i.e. price of locally registered
products
 COMMON REASONS FOR DELAY
• Incomplete dossier.
• Dossier not as per ICH guidelines.
• Stability studies not as per GCC guidelines.
• Bioequivalence studies not as per GCC guidelines.
• Product did not complete 1 year marketing in
country of origin.
• Late replies from the manufacturer’s regulatory
dept.
Medical Device Regulations
 MEDICAL DEVICE
(AR)
• Appointment of Authorized Representative
(AR)
– Distributor
– SFDA approved consultancy office
• AR agreement to be legalized from Saudi
Embassy in country of origin
• Registration of AR agreement in SFDA
• Could be for one year or more
• Online process
 MEDICAL DEVICE
(MDMA)
• Medical Device Marketing Authorization
(MDMA)
• Product to be approved from any of the
authorities from FDA / CE / PMDA / TGA /
Health Canada
• For 3 years or more linked with the validity of
the reference authority approval.
• Online process.
 MEDICAL DEVICE
(MDMA – Critical Factors)
• Manufacturer address on all different
certificates should match.
• MDMA certificate validity matches with the
reference authority certificate validity. Try to
have the latest certificate with longer validity
before submission.
• Validity of notified body audit report should
be at least more than one year.
• Product to have barcode.
 MEDICAL DEVICE
(MDC)
• For borderline products SFDA may ask for
official product classification (MDC) after
submission of MDMA.
• Requirements:
– Product ingredients
– Label
– IFU (Instruction for USE)
– Product brochures
– Reference authority registration
THANK YOU