Version 1.

Date of implementation 1 February 2017

Registration of Products According to
Verification and Abridged Process

Version 1.2

Drug Sector
Saudi Food & Drug Authority

Please visit SFDA’s website at

[Link]
for the latest update

For Inquiries [Link]@[Link]

For Comments or Suggestions [Link]@[Link]

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 Drug Sector

Vision and Mission

Vision
To be the leading regional Drug Regulatory Authority for pharmaceuticals and cosmetic
products, with professional excellence and services that contribute to the protection and
advancement of public health in the Kingdom of Saudi Arabia.

‫الرؤية‬
‫ر‬
‫ ويقدم خدماته بمهنية مت ر‬،‫ومستحضات التجميل‬ ‫ً ر‬ ً
‫مية‬ ‫أن يكون قطاع الدواء رائدا إقليميا يف الرقابة عىل األدوية‬
.‫تسهم ر يف حماية وتعزيز الصحة ر يف المملكة العربية السعودية‬

Mission
Protecting public health by ensuring safety, quality, efficacy and accessibility of human,
veterinary drugs and biological products, and safety of cosmetics, through administration of a
national regulatory system which is consistent with international best practice. Through our
mission, we also provide accurate and scientific-based information to the public and healthcare
professionals.

‫الرسالة‬
‫حماية الصحة العامة من خالل ضمان أمان وجودة وفعالية وتوفر األدوية ر‬
‫البشية والبيطرية والمنتجات الحيوية‬
‫وطن للرقابة متوافق مع أفضل الممارسات الدولية وتقديم المعلومات‬‫عي تطبيق نظام ر‬ ‫وسالمة مواد التجميل ر‬
‫ي‬
‫ر‬
.‫الصحيي‬ ‫ر‬
‫والمهنيي‬ ‫الدوائية المبنية عىل أسس علمية للعامة‬

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Document Control

Version Author Date Comments

1.0 Drug Sector 1 February 2017 Published as a memo

Standards Setting Update and including FAQs

1.1 3 August 2017
Directorate

Executive Including veterinary

1.2 Directorate of 9 October 2018 products and other update
under the requirements
Regulatory Affairs
section

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Table of Contents

I. Introduction: ...................................................................................................................... 6
II. Definitions .......................................................................................................................... 6
III. General considerations .................................................................................................... 7
IV. Requirements .................................................................................................................... 7
V. Timeline ............................................................................................................................. 9
VI. Important Note ................................................................................................................ 9
VII. Frequently Asked Questions (FAQs) .......................................................................... 10

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 I. Introduction:
The Drug Sector in the Saudi Food & Drug Authority (SFDA) has developed this document
to provide assistance for stakeholders on how to proceed the verification and abridged
registration for human and veterinary products.

It is important to note that the SFDA reserves the right to request information or defined
conditions not specifically described in this document, in order to allow the administration
to adequately assess the safety, efficacy and quality of drug products. The SFDA is
committed to ensuring that such requests are justifiable and decisions are clearly
documented.

This document should be read in conjunction with the other relevant and applicable
guidance documents.

The confidential information submitted by the companies to support their registration

application is protected and will not be shared by any means with other parties.

II. Definitions
 Verification Registration: a process where a product has been approved and
marketed by BOTH of the following drug regulatory agencies;
The U.S. Food and Drug Administration (FDA) and the European Medicines
Agency (EMA).
 Abridged Registration: a process where a product has been approved and
marketed by either of the two drug regulatory agencies;
The U.S. Food and Drug Administration (FDA) or the European Medicines Agency
(EMA).

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III. General considerations
 The registration by verification or abridged only applied for New Products (New
Chemical Entity) and Biological Products (excluding blood products and
vaccines).
 The eligible product must be submitted to the SFDA within two years from the date
of approval by the reference drug regulatory agencies ([Link] and/or EMA).
 The eligible product does not need a more stringent assessment as a result of
different local disease patterns and/or medical practices.
 The product and its intended use (indications, dosage information, and patient
groups (for human product) and target animal species (for veterinary product)) has
not been rejected, withdrawn, suspended by any drug regulatory agency for safety
and/or efficacy reasons.

IV. Requirements
 A complete eCTD file:
o For human products: according to the GCC data requirements of human
drug submission. The eCTD submission should be the same as the reference
drug regulatory agency (US FDA and/or EMA) for modules (2-5).
o For veterinary products: according to the data requirements for veterinary
medicinal products. The eCTD submission should be the same as the
reference drug regulatory agency (US FDA and/or EMA).
 In module 1 (for human product) or part 1 (for veterinary products) and under
Additional Data Section, applicant must add the followings:
o Complete assessment report and other relevant supporting documents from the
reference agency (US FDA and/or EMA) according to the followings:
- verification process: the followings are required from the both reference
drug regulatory agencies (FDA and EMA):

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 a. Complete clinical and quality assessment report including (if
applicable) assessment on the Question & Answer documents
between the Sponsor and Agency and all annexes.
b. Assessment reports and/or documents pertaining to post-
approval variations (if applicable).
- Abridged process: the same requirements as for Verification process but
only from either of the two reference regulatory agencies (the US FDA
or the EMA).
o For both registration processes, the submitted assessment reports must be
unredacted or unedited, and should include details of imposed licensing
conditions, final product labelling, chemistry and clinical review, and other
information in relation to the product’s approval. Report obtained from the
public domain are deemed unacceptable.
o For the site inspection procedures, the company has to pay the inspection fees
and submit valid GMP certificate from local authority and other international
authorities, copy of Site Master File (SMF), list of all products that
manufactured at the site and supplied to Saudi Arabia, last inspection report
(in English) from local authority and other international authorities.
 A stability study according to the GCC guidelines for stability testing.
 A declaration letter issued by the product owner/applicant stating that all aspects of
the drug product’s quality, including but not limited to the formulation,
manufacturing site(s), release and shelf life specifications , primary packaging and
active pharmaceutical ingredient(s) source are identical to that currently approved
by the chosen primary reference agency at the time of submission. However, a
different type of the container closure system (e.g. Alu/Alu blister vs. HDPE bottle)
may be proposed to meet GCC stability requirements.

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V. Timeline
Process Timeline

Registration through verification Within 30 working days

Registration through abridged Within 60 working days.

VI. Important Note

Approval by these reference drug regulatory agencies does not oblige the SFDA to approve
the application.

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VII. Frequently Asked Questions (FAQs)
This section includes answers of the most frequently asked questions about the verification
and abridged process:
 Scope:
- Will SFDA accept the product registration via the decentralized procedure in
Europe?
EMA registration means centralized procedure.

- What is the situation for product approved by Health Canada, PMDA, Swiss
Medic or TGA?
Only FDA and EMA are accepted as an approval references.

- If the product is generic and it is lifesaving, is it possible to apply through

verification and abridged process?
The registration by verification and abridged is accepted only for new products
(NCE) and new biological products.

- Will the SFDA accept to register the biosimilar products through verification
and abridged Process?
Only new biological is accepted.

- Is the new registration process applicable for combination products (of well-
known active ingredients) that have together a new indication and has received
EMA and US registration approval?
Yes, it is

- Does the verification and abridged process apply to variations like new
indications addition of already registered products with the SFDA?
Currently, verification and abridged only for product’s registration.

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 File submission:
- Is it possible for a product under review by the SFDA to be transferred into
the verification and abridged process or does the new process only apply to a
product submitted after the announcement?
It is applicable for products submitted before Feb-2017 and are still under
registration taking into consideration the two years duration from the date of
approval. However, applicants have to submit an updated file according to the
verification and abridged requirements.

- What counts as proof of product registration?

For human products: Refer to the GCC data requirements section 1.7.2 (CPP or free
sale).
For veterinary products: Refer to the data requirements for veterinary medicinal
products section 1a42 (CPP).

- If conditional approval granted by FDA / EMA can the company apply to

SFDA using the conditional approval?
Yes, it can. The applicant has to submit evidence of approval.

- What are the file’s requirements to submit the product through verification
and abridged process?
Refer to the section of requirements.

- For products their sites are not registered at SFDA, does SFDA approve the
product without site inspection?
Site inspection will not be a barrier for the product registration. SFDA will take the
necessary actions to maintain the registration within the time-frame.

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 - Regarding the submitted assessment reports and since these reports belong to
another authority & may contains personal data of the assessor, quality and
manufacturing trade secrets…etc. , will the SFDA accept the file if these data
removed ?
All information regarding the drug approval is required to accept the file. Other
information such as personal data can be excluded.

- If product comply with requirements of verification / abridge procedure, does

the submission require an appointment or could be done via direct
submission?
The applicant shall follow the Guidance for Submission and the Regulatory
Framework for Drug Approval.

- If the product (has different strengths) is registered in FDA/EMA, and the

company submit only one strength through verification and abridged Process.
SFDA encourage the company to submit all strengths registered in FDA/EMA at
the time of submission.

 General:

- If company could not perform stability data on GCC zone according to the
GCC guidelines on stability testing, can SFDA approve the data on Zone II?
Any deviation from GCC zone should get prior approval.

- What if the EU and US labels are different (e.g. differences in approved

indications)? Which one will be followed by SFDA? Can the applicant suggest
the primary reference country?
For verification registration, the applicant should assign a primary reference
authority and the complete assessment report and other relevant supporting
documents must be submitted.

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- In case of differences for example: manufacturing site, release and shelf life
specifications, primary packaging and API source; will the SFDA accept to
register the product through verification and abridged procedure?
The submitted file must include a declaration letter stating that all aspects of the
drug product’s quality, including but not limited to the formulation, manufacturing
site(s), release and shelf life specifications, primary packaging and API source are
identical to that currently approved by the chosen primary reference authority.

- Is the current pricing rules part of the verification and abridged?

Yes, it is.

- Is the product testing part of the verification and abridged?

Yes, it is and refer to the Regulatory Framework for Drug Approvals.

- Will SFDA review the Arabic translation of leaflet, label and carton during
the registration process?
Yes, it will.

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