Saudi Food & Drug Authority issues new and updated guidance documents – a Q1 & Q2 2024 update

The Saudi Food & Drug Authority (“SFDA”) has issued a new version of the Guidance for Priority Review of Product Registration, V 5.3

The last version, version 5.2, was updated in 2022 and added the criteria for both first generics and biosimilars qualifying for priority review designation. The priority review process for the first generic drug was intended for the product considered the first generic to the innovative product that is already registered in SFDA. However, this new Version 5.3 removed the criteria for the first generic qualifying for priority review designation. The drug types that may request priority review designation are:

Human Drugs:

1. New drug
2. Biosimilar
3. Biologic

Veterinary Product

1. New drug
2. Biologic

Radiopharmaceutical

The SFDA issued a new document, Conditional Approval for Human Use, Version 1

Conditional approval is issued when technical requirements that must be provided in the dossier are not met or completed and the benefits of the product outweigh its potential risks, as determined by SFDA. SFDA has adopted this accelerated pathway to facilitate timely access of promising new therapies while ensuring the scientific rigor of the assessment of their quality, safety, and efficacy.

However, conditionally approved medicinal products are exclusively for government health sector supply. The conditional approval is effective for two years, as this approval is not intended to remain conditional indefinitely. Up to two extensions, each of 2 years are available, resulting in a possible maximum conditional approval period of 6 years.

This new guidance document sets out the eligibility requirements, obligations, rules on the granting of such a ‘Conditional Approval’ for new human medicines, including biologics. Specifically, this document applies to new medicinal products (including biologics) for human use that belong to one of the following categories:

1. Medicinal products that aim at the treatment, the prevention or the medical diagnosis of seriously debilitating diseases or life-threatening diseases; or
2. Medicinal products to be used in emergency situations, such as in the situation of a pandemic; in response to public health threats duly recognized either by the World Health Organization or by the Ministry of Health of Saudi Arabia.

The SFDA issued new version of the Data Requirements for Herbal & Health Products Submission, Content of Dossier, Version 3.0

Amongst other additions and modifications, the SFDA added requirements that in Module 1:

• a declaration letter is submitted on the patent status of the product; and
• a Marketing Authorization holder section, which should contain an “Authorization Letter” on a “Finished Product Manufacturer” letterhead appointing the “Marketing Authorization Holder” (which is a company that owns the right to market the product in the Kingdom and is fully responsible for its quality, effectiveness, safety and post-marketing surveillance after it is marketed as well as related procedures from the sale, withdrawal or discard.).

The SFDA issued a new document, General Considerations for Preclinical Studies Submissions, Version 1.0

Every submission to the SFDA is required to include certain preclinical data to support the safety and efficacy of the pharmaceutical product. The required preclinical data depends on the type of submission. This guidance provides recommendations on the minimum preclinical data requirements for human medicinal and biological products. It applies to data supporting clinical trials applications and marketing authorization / variation applications (including impurity qualification) of chemical and biological pharmaceutical substances and products.

This document is composed of two parts:

1. Part A of the document is intended as a guidance tool for applicants to ensure that the minimum required preclinical data to establish the product’s safety and efficacy are included in the applicant’s submission; and
2. Part B of the document is a writing guide, which provides guidance to applicants in regard to the format and content of the non-clinical data submitted to the SFDA.

The SFDA reserves the right to request information or material not specifically described in this guide in order to assess the safety, efficacy, or quality of a therapeutic product. The guide is to be read in conjunction with other applicable SFDA documents, as well as the International Council for Harmonization (ICH) guidelines that are implemented by SFDA.

The information discussed in this new guidance does not apply to veterinary and herbal product submissions.

The SFDA issued a new version of the Guidance for Products Classification, Version 7.0

Some of the main changes in the new version are:

Adds a new section on “regulation of raw materials”;

1. Raw materials regulation in SFDA depends on several criteria, such as the statutory definitions, the manufacture intended purpose, and the current SFDA’s regulations and standards.
2. SFDA has published a guidance to provide manufactures and stakeholders with information regarding the regulatory path of these materials.

Updates the classification and regulatory path of food supplements;

SFDA has updated the regulation of food supplements and issued a circular to clarify the classification criteria. Food supplements will be classified as “Pharmaceutical Product” if meets any of the following criteria:

1. Contains medicinal herb(s) or herbs with medical intended purpose: Herbal Product;
2. Concertation(s) is/are above the daily allowed limit stated in technical standards SFDA.FD 55: Human Pharmaceutical Product;
3. Intended to treat, prevent and/or diagnose a human disease: Human Pharmaceutical Product;
4. Contains active medicinal/ pharmaceutical ingredient:
   Human Pharmaceutical Product;
5. Not intended for ingestion such as topicals, inhalers, suppositories. Etc:
   Human Pharmaceutical Product;
6. Concertation(s) is/are within the daily allowed limit stated in technical standards SFDA.FD 55 and intended to treat, prevent and/or diagnose a human disease:
   Health Product;
7. Products contain: fatty acids, amino acids, enzymes, prebiotics and probiotics, collagen, dietary fibers, and intended to treat, prevent and/or diagnose a human disease: Health Product.

• See also, Circular 1337 Updating classification criteria for food supplement.
• Food supplements must comply with technical standards SFDA.FD 55 Food Supplements.
• Updates to the customer-made medical devices section;
• Products for clearance section added, detailing that some products do not need a marketing authorization/ registration application; however, a clearance approval must be obtained in order to permit the entry of the product into Saudi Arabia. Products in this category may include but are not limited to:
  • Unregistered Drug or Products;
  • Unregistered Veterinary Products;
  • Samples;
  • Raw Medical Plants;
  • Animal grooming;
  • Proficiency Test samples for food products;
  • Medical Devices (see SFDA MDS-REQ 5, Clearance for Requirements of Medical Devices); and
  • Food (see SFDA Food Clearance Conditions and Requirements).

The SFDA issued a new document Guidance on the Development of IVDs for In-House Use, MDS-G022, V1.0

SFDA guidance MDS-G009 defines and clarifies the requirements of manufacturers of point of care (“POC”) medical devices. In-house in vitro diagnostic (“IH-IVD”) medical devices are a subset of POC medical devices. This guidance outlines the development and post market activities for IH-IVD medical devices.

IH-IVDs may have been designed in-house, could use components that have been brought together and given a medical intended purpose, or could be a commercial kit where the lab has changed the intended purpose that includes changing sample type or population.

The quality management system (“QMS”) section of the guide describes the general requirements for in-house assays in KSA and creation of performance data and documents required. This documentation may be required to be submitted to SFDA on request and should therefore be available.

The design and development should align with the core requirements, detailed in the guide, that should be defined and documented in the quality system in order to generate data and records that provide objective evidence of the design process.

Further, the tests need to be designed to meet the needs of patients, clinicians and should be state of the art – they need to produce clinically relevant information to support medical practice. The Essential Principles (set out in MDS-REQ1, Requirements for Medical Devices Marketing Authorization) should be considered throughout the design of the test according to the QMS and the data generated must support the intended use of the test as described in labelling and on Medical Device Application Form MDS – G009 Annex 1. There are many elements to consider when describing the intended use; Table 1 includes a non-exhaustive list of considerations.

Other topics covered by the guide are risk, performance, manufacture/production, labelling, packaging and transport of the IH-IVD within the laboratory, and post-market surveillance.

The SFDA issued a new document, Guidance for Surgical Sutures, MDS-G021, Version 1

The purpose of this document is to assist the manufacturers and authorized representatives of surgical sutures with/without needles, used for general soft tissue approximation and wound closure/ support, to comply with the SFDA Requirements for Medical Devices Marketing Authorization (MDS-REQ 1). This document does not add any requirements related to compliance with the essential principles of safety and performance, which are specified in MDS-REQ 1; rather, it just indicates some information and guidance of surgical sutures related characteristics.

The SFDA issued a new document, Guidance on Biotechnology-based Medical Devices, MDS-G016, Version 1

The guidance applies to biotechnology-based medical device manufacturers. The guidance aims to: clarify regulatory and technical requirements to be taken into consideration during the design and manufacturing stages of biotechnology-based medical devices and its products; clarifying lists of relevant standards and guidelines; as well as provide important contact information and links.

The SFDA issued a new version of the Good Manufacturing Practice for Blood Establishments guideline, Version 3.0.

A variety of new key definitions were added, as well as: a new section on data processing systems, for when computerized systems are used; a new section regarding the control of equipment and materials; requirements for the release of blood and blood components and standard operating procedures; new sections on donor eligibility, collection of blood and blood components, and testing for infectious markers; amongst other updated and additions.

Each blood establishment must develop and maintain a “Quality System” that is based on the principles of “Good Manufacturing Practices” (“GMP”). For blood and blood components imported from countries outside Saudi Arabia and intended for use or distribution in Saudi Arabia, there must be a “Quality Management System” for blood establishments in the stages preceding importation equivalent to the “Quality Management System” established in Saudi Arabia.

A variety of further updates and new guidelines are expected over the remainder of this year.