Key Saudi Medical Device and Pharmaceutical Regulatory Developments of 2023
Healthcare &Life Sciences Focus
This year, we expect the next few years to bring further significant announcements and regulatory changes as the Kingdom’s Vision 2030 programme is well underway.
Law Update: Issue 364 - Healthcare & Life Sciences Focus
Christina SochackiSenior Counsel,Corporate Commercial
As anticipated, the increase in regulatory activity over the last few years across the Middle East has still not slowed down. With a vast array of significant healthcare transformation announcements coming out of the Kingdom of Saudi Arabia (‘KSA’ or ‘Saudi’ or ‘Kingdom’) this year, we expect the next few years to bring further significant announcements and regulatory changes as the Kingdom’s Vision 2030 programme is well underway.
Staying on-top of the updates and new regulations, circulars, and guidance from the Saudi Food & Drug Authority (‘SFDA’) is no longer a passive exercise; things are changing too quickly. Set out below, we summarise the key new or updated pieces of legislation pertinent to pharmaceuticals, biologics, medical devices and other medical products in the KSA issued in 2023, through November.
SFDA Product Classification Guidance V. 7 – new versionA new version of the SFDA Products Classification Guidance was issued to update a variety of sections. Of particular note are: the addition of a section concerning the regulation of raw materials; an update to the classification and regulatory path of food supplements; incorporating Circular 26119’s restrictions on Azelaic Acid in cosmetic products; included cryotherapy devices with medical intended use under the classification of “general health products”; a new section on products for clearance 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; and additional examples of products not under SFDA’s jurisdiction.
SFDA Guidance for Borderline Products Classification v 3 – new versionThis guidance addresses the SFDA’s understanding of borderline products; and helps to clarify the areas where the borderline exists between two or more regulations. Moreover, this guidance explains the classification criteria and the approach to determine the most appropriate regulatory path when there is doubt or difficulty in classification.This new version updates the illustrative examples of borderline classification decision set out in Appendix 1. For example, Ascorbic Acide (vit c) effervescent tables may be classified as a food product where it satisfied the food supplement definition and complies with the technical standard of food products, as well as had a concentration within the daily allowed limit.
Guideline on the Scientific Data Requirements for Plasma Master File (PMF) v 1.3 – new versionThis new version is adopted from the European Medicines Agency (‘EMA’) and updates the plasma-derived products’ list and provide further details regarding compliance with European Pharmacopoeia Monographs.
Guidance for Presenting the Labeling Information, SPC, and PIL v 3.3 – new versionThis new version added requirements for statements concerning hazardous drugs as well as additions to Appendix 1, “Storage conditions are required to be translated into Arabic language for medicines used solely in hospitals.”
Guidance on Classification of Advanced Therapy Medicinal Products – new documentThis new guideline provides definitions for Advanced Therapy Medicinal Product (‘ATMP’) in Saudi Arabia. As detailed by the guideline, the aim of this ATMP Guideline is to provide guidance on the ATMP definitions, as well as on the interpretation of key concepts of the definition of gene therapy medicinal products and cell based medicinal products, and combined advanced therapy medicinal products. The ATMP classification will help developers to clarify the applicable regulatory framework.
According to the guideline, ATMP classification will be based on the evaluation of whether a given product fulfills one of the definitions of Gene Therapy Medicinal Product (‘GTMP’) or Cell Based Medicinal Product (‘CBMP’), and whether the product fulfills the definition of a combined ATMP or not.
However, due to the complex nature of these therapeutic products, the limited data package at an early stage of product development and the rapid evolution of science and technology, questions of borderline may arise. These will be addressed by SFDA on case-by-case basis. SFDA provides a consultation service through the electronic product classification system ePCS https://pcs.sfda.gov.sa/Default.En.aspx. Applicants are advised to submit classification requests via the electronic system.
Since clinical trials for ATMPs are under the responsibility of SFDA, it is important to stress that the ATMP classification may help when submitting clinical trial application, as the applicant and SFDA will clarify and facilitate identification of the most relevant criteria and procedure to be applied.
The SFDA’s new breakthrough medicines program aims to facilitate and accelerate development and review of new drugs that address unmet medical need in the treatment of serious or life-threatening conditions.
Under the breakthrough medicine program, the designation request may submitted by the end of phase 2 or at any time after. All four criteria must be fulfilled in order to gain a breakthrough medicine designation:
Target serious debilitating or life-threatening conditions with unmet medical need;
The medicinal product is likely to offer major advantage over methods currently used;
The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance; and
The product is not registered at any regulatory authority at the time of submission of the designation request.
Following granting of the designation, an applicant must submit the medicine application file within 30 working days after granting the designation. The application shall be submitted through Saudi Drug Registration (SDR) System and according to the SFDA’s “Guidance for Submission”. The applicant may request an exemption for one or more of the registration requirements, if unavailable (e.g. CPP, leaflet and artwork). The scientific assessment takes 60 working days. When the SFDA has sufficient information about the product, it will make a decision on whether or not a medicine should be granted a marketing authorisation.
Importantly, the company can start the medication access negotiation process with all involved healthcare entities in parallel with application review.
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:
Medicinal products that aim at the treatment, the prevention or the medical diagnosis of seriously debilitating diseases or life-threatening diseases; or
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.
Products Recall Guidance – new documentThis new guidance covers the recall requirements and the procedure for:
drugs intended for use in human and animals;
human herbal products; and
human health products.
There are two types of recall actions:1) recall; and 2) recall for product correction, such as to modify, adjust, re-;abel, or provide updated instructions for use. Based on the recall level and classification, type of health hazard on the patient, and the availability of the product, SFDA may issue:
A recall circular to all healthcare institutions, if appropriate (it will be published on the SFDA website);
A recall notification to healthcare professionals; or
A public alert through appropriate channels if a recall action is to be conducted at the consumer level.
This guidance outlines the role and responsibilities of each party involved in the recall action. In addition, the guidance will help to understand and comply with articles of the Implementing Regulations of the Law of Pharmaceutical and Herbal Establishments and Products that relate to recalls action.
A product might be subjected to recall it was suspected of being potentially harmful to users due to its defective quality, safety or efficacy. All related information must be reported to the Product Quality Department (‘PQD’) and National Pharmacovigilance and Drug Safety Center (‘NPC’) at the SFDA.
Child Resistant Packaging Requirements – new documentThis new guidance was issued on 6 August 2023, and will come into force on 6 February 2025 for new medicinal products that are seeking initial marketing authorization as well as for registered medicinal products. However, companies are encouraged to submit variation applications for registered products as early as possible to incorporate the necessary requirements.
This document applies to medicinal products that is:
Intended to be administrated orally;
Supplied in a reclosable package; and
Contains a substance, or a salt, ester, or other derivatives of a substance, that is specified in the list of products in the guidance document.
This guidance does not apply to a medicine that is:
used by, or administered to, a patient for treatment in hospital settings; or
in a container intended only as a bulk medicine pack.
For new drug submission, detailed information on child resistant packaging should describe according to the GCC Data Requirements for Human Drugs Submission, the Container / Closure system (section 3.2.P.7). For registered products, and in case of changes in the qualitative and quantitative composition of proposed packaging, the variation request should include detailed information on the Container / Closure System (section 3.2.P.7) and the request should be in accordance with the Guidelines for Variation Requirements.
Clinical Considerations for Efficacy and Safety Assessment – new documentThis document describes the clinical data required for human medicinal and biological products registration at the SFDA. It applies to data supporting new applications for drug, biologic, generic drug applications, and type II variations regarding changes to therapeutic indications.
The information discussed in this document does not apply to veterinary and herbal product submissions.
This new document is meant to be a guidance tool for applicants to ensure the availability of minimum clinical data required in the submission to establish the safety and efficacy of the product. The SFDA encourages applicants to discuss the outcome of the clinical evaluation, if needed, in the context of this guidance.
Guidance for Orphan Drug Designation – new documentThis new guidance provides information to the sponsor on how to submit an application to designate the orphan drug designation (‘ODD’), at any stage of the development of the human medicinal product and before submitting the marketing authorization application. The potential orphan drug must be:
An unregistered drug in SFDA, or
An already registered drug in SFDA with a new orphan indication, or a new dosage form, or
other major variation applications that meet all relevant criteria of ODD.
Designated orphan drugs can apply for certain measures and incentives to support the research and development, registration and marketing activities.
Guideline on the Braille Requirements for Labelling Information of Medicinal Products for Human Use – new documentOn 1 June 2023, the SFDA issued this new guideline, which interprets the requirements for Braille on the packaging of human medicinal products to be available in formats for blind and partially sighted people. The Braille requirements does not apply to the packaging of medicinal products solely for hospital use or administered only by health care professionals; for example, it is not required to put the name in Braille for vaccines.
For new medicinal products seeking marketing authorization, the final version of this document is effective after 3 years following the adoption date of the guideline. After 5 years of publishing the final version of this document, the implementation is mandatory for all registered products. Nevertheless, companies are encouraged to submit a variation application to implement the requirement of the guideline as soon as possible.
Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances (VICH GL39) – new documentThis new document was adopted from the revised version of the Veterinary International Conference on Harmonization (‘VICH’) Guideline 39. This guideline assists in the establishment of a single set of global specifications for new veterinary drug substances and medicinal products. It provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin, and new medicinal products produced from them.
Guide to Good Manufacturing Practice for Medicinal Products v 4.2 – new versionGood Manufacturing Practice (‘GMP’) is part of quality management, which ensures that products are consistently produced and controlled to applicable quality standards. The SFDA’s update to its guide to GMP for medicinal products by revising Annex 1 “Manufacture of Sterile Medicinal products”, which updates became effective on 25 August 2023.
The Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products Guideline v 4 – new versionArticle 20/4 of the Implementing Regulations of the Law of Pharmaceutical and Herbal Establishments and Products, requires the registration committees to conduct certain updated tasks; this new version incorporates such updates and sets the regulatory frameworks for registering pharmaceutical, herbal and health product manufacturers and their products
Guidance on Good Pharmacovigilance Practices (GVP) v 3.1 – new versionWhilst the prior version, v3, made a variety of clarifications (including in relation to the qualifications of the qualified person responsible for pharmacovigilance in KSA, delegation of pharmacovigilance tasks to third parties, new requirements for pharmacovigilance consultation service agencies, and a variety of other clarifications, additions, and deletions), this latest version simply changes, in Section VI.C.2.1.6 “Emerging Safety Issues”, the notification of events/observations that may affect the benefit-risk balance of a medicinal product from three working days to seven calendar days.
Requirements for Clinical Trials of Medical Devices v 4.1 (MDS-REQ 2) – new versionThis new version of the document specifies and clarifies the requirements for conducting clinical trials of medical devices within KSA. This document applies to contract research organization (‘CRO’) or other parties wishing to conduct clinical investigations of medical devices or clinical performance studies of in vitro diagnostics medical devices within KSA. This new version mainly updates the terms and references in the document to align with the KSA Medical Device Law and its executive regulations. For example, the reference to guidance MDS-G31 was replaced by MDS-REQ 11 with regard to reporting and investigating serious adverse events or device deficiencies related to the clinical trial.
Guidance on Manufacturing Paths of Medical Devices (MDS-G011) – new documentThis document applies to local manufacturers of medical devices (whether complete, partial, contract, or contract purchase manufacturing). The purpose of this document is to clarify paths of manufacturing medical devices locally (including the transfer of its technology and its settlement in the KSA), its circulation, distribution within the KSA and exportation, in addition to guide manufacturers to the SFDA requirements published on its website.
Guidance on MDMA Significant and Non-Significant Changes (MDS-G012) – new documentThe purpose of this document is to clarify the requirements, with examples, of reporting or notifying the SFDA of significant and non-significant changes to marketing authorized medical devices/supplies (including IVDs), referred to in the Medical Device Law’s executive regulations and “Requirements for Medical Devices Marketing Authorization (MDS-REQ1)”/Section (5).
Guidance for Points of Care (POC) Medical Devices Manufacturing (MDS-G009) – new documentThis document applies to healthcare providers wishing to manufacture medical devices within their facilities for their own use and for non-industrial scale (with regard to the magnitude and methods of production). This document applies to the following activities:
manufacturing of medical devices using 3D printer inside a healthcare facility;
manufacturing according to the Medical Device Production System (‘MDPS’);
in-house IVD; and
all medical devices modified or developed within healthcare facility.
This new guidance replaces the Guidance on Patient-matched Medical Devices Using 3D Printers (MDS-G30
Guidance on Medical Devices Samples Collection v 4 (MDS REQ-G013)The purpose of this document is to clarify the procedures of medical devices samples collection for laboratory testing in order to ensure their quality, safety, and effectiveness, and their conformity with the standards approved by the SFDA. This new version provided a number of editorial modifications only.
Requirements for Post-Market Surveillance of Medical Devices v 2 (MDS-REQ 11) – new versionThis new version mainly makes a series of editorial modifications. This document applies to the following procedures and activities:
Reporting and investigation of adverse events and complaints of medical devices
Reporting violating medical devices
Safety alerts and field safety corrective action (FSCA) for medical devices
Appointing a contact officer with the NCMDR
Reprocessing of medical devices
Resale, loaning or donating used medical devices
After-sale and maintenance services for medical devices
Destruction of used medical devices.
Requirements of Importation and Re-Exportation for Radioactive Materials Used in Medical Applications v 1.1 (MDS-REQ 6) – new versionThis document was first issues last year, replacing MDS-G24 v2, dated 01/01/2021, and reflected the new Medical Devices Law and its executive regulations. This new version no longer provides a prescribed form of the “Radioactive Material Transportation Agreement” required to be submitted (previously provided in Annexure 2).
Requirements on Transporting and Storage for Medical Devices v 3 (MDS-REQ 12) – new versionThe purpose of this document is to specify and clarify the requirements of storage and transportation of medical devices/supplies. This new version replaces the “Guidance on Requirements for Storage, Handling and Transportation of Medical Devices (MDS-G25)”. It also updated and amends the background according to Medical Device Law and its Implementing Regulation.
Requirements for Shipments Clearance Medical Devices at Ports of Entries v 6 (MDS-REQ 5) – new versionVersion 5 updated the document from MDS-G21 to MDS-REQ5 and now this new version 6 provides further updates to comply with the KSA Medical Device Law and its executive regulations, such as unifying this document to include a variant of other guidance documents (such as Guidance on Importation Requirements of Medical Devices Intended for Demonstration or Training Purposes Only MDS-G8, v3 dated 27/12/2020; and Guidance for Medical Device Importers and Distributors, v2 dated 26/11/2011).
This version 6 further develops the requirements of importation:
for Circulation of Medical Devices;
of Used Medical Devices;
for Humanitarian Purposes; and
for Clinical Studies.
Requirements for Safe Use of Medical Devices Inside Healthcare Facilities v 2 (MDS-REQ 3) – new versionThis guidance was released for the first time last year; this new version modified a number of requirements regarding radiation emitting devices and materials. Further, the previously standalone document, “Requirements on Radiation Protection and Safety for Healthcare Providers” has now been integrated into this document.
Overall, the guidance sets out the requirements for safe use of medical devices and radioactive medical materials inside healthcare facilities in order to ensure safety, efficiency and quality of them, and reduce potential risks corresponding to use and handle them inside healthcare facilities.
We do not expect legislation developments to slow down anytime soon. Stay tuned for more updates by following our LinkedIn page: https://www.linkedin.com/showcase/middle-east-healthcare-al-tamimi-company/.
For further information,please contact Christina Sochacki.
Published in January 2024
