These guidelines are adopted from the European Medicines Agency (EMA) Guidelines on the requirements of the chemical and pharmaceutical quality documentation concerning investigational products in clinical trials.
1.1 Objective
This guidance outlines the required documentation for the chemical and pharmaceutical quality of investigational products dossiers for small molecules. It covers chemically defined drug substances, synthetic peptides, herbal substances, herbal preparations, and chemically defined radioactive/radiolabeled substances that must be submitted to the Saudi Food and Drug Authority for approval before starting a clinical trial in humans
1.2 Scope
These guidelines specify the documentation required for the chemical and pharmaceutical quality of small molecule investigational products (IP) dossiers submitted to the Saudi Food and Drug Authority (SFDA) for clinical trial approval. They apply to:
• Chemically Defined Drug Substances
• Herbal Substances and Preparations
• Chemically Defined Radioactive/Radiolabeled Substances
1.3 General points concerning all IPs
IPs should be produced in accordance with the principles and the detailed SFDA guidelines of Good Manufacturing Practices for Medicinal Products.
1.4 Submission of data
The IP should be provided in a clearly structured format following the numbering system as given in the chapters 2 to 8 of this Guideline. However, the first Arabic number being introduced only to facilitate the Guideline’s use should be omitted. The IP should include the most up-to-date information relevant to the clinical trial available at time of submission of the clinical trial application.
1.5 General considerations
For drug substances or IPs to be used in clinical trials as described in chapters 2 to 8, Reference to either United States Pharmacopoeia Reference Standards, European Pharmacopoeia Reference Standard, International Pharmacopoeia Reference Standard or the British Pharmacopoeia Reference Standard is acceptable. For active substances, the suitability of the referenced monograph to adequately control the quality of the active substance (impurity profile) will have to be demonstrated by the applicant/sponsor. Suitability of monographs of the European Pharmacopoeia (Ph. Eur.) can be demonstrated with certificates of suitability (CEP) issued by the European Directorate for the Quality of Medicines (EDQM). In other cases, information on the synthesis of the drug substance, including reagents, solvents, catalysts and processing aids, should be provided.
For generic bioequivalence studies as described in chapter 5 which will support a Marketing Authorisation Application in Saudi Arabia, applicants/sponsors are advised that reference to the Ph.Eur. will facilitate future licensing activities in the KSA.
For impurities in IPs, a justification that the product is safe for its intended use, considering the anticipated exposure of volunteers and patients, respectively, will be required.
When compiling the documentation, the difference between “analytical procedure” and “analytical method” should be kept in mind. The term “analytical procedure” is defined in ICH Q 2 (A) and refers to the way of performing the analysis. The term “analytical method” refers to the principles of the method used.
1.6 Labeling and Packaging Requirements:
The labeling and packaging of IP’s should follow the SFDA IP Labeling and Packaging Memo.
1.7 Regional Administrative Information
1.7.1 Alcohol-content declaration
This section shall contain a declaration letter stating that the investigational product is free from alcohol. In the case of alcohol come into existence in the investigational product, a pre-approval from the authority is required along with the justification to make it possible for the authority to evaluate the request and send the respond to the applicant.
1.7.2 Pork-content declaration
This section shall contain a declaration letter stating that the investigational product is free from any materials of pork/porcine source.