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Veterinary vaccines submitted for approval must satisfy quality, safety, and efficacy standards. All veterinary vaccines must undergo non-clinical testing to establish their safety and efficacy profiles. Evaluation of non-clinical components is an integral part of evaluating the benefits and risks of the veterinary vaccine before approval. The overall evaluation process depends on the quality of the submitted non-clinical data. The types of non-clinical studies required depend on the type of application. This document provides general guidance on the non-clinical data requirements for veterinary vaccine submissions to the Saudi Food and Drug Authority (SFDA).
This guidance applies to non-clinical data supporting veterinary vaccine applications seeking authorization. It is intended to define the data requirements for non-clinical studies of veterinary vaccine applications, which must be conducted in accordance with the principles of veterinary good clinical practices (VICH GL9) and Good Laboratory Practices (GLP). The information outlined in this document does not apply to pharmaceutical and herbal veterinary products submissions. This document is composed of two main parts:
- Veterinary vaccine non-clinical data requirements: intended as a guidance tool for applicants to ensure that the minimum required non-clinical data to establish the product’s safety and efficacy are included in the applicant’s submission.
- Final report requirements and writing guide: writing guide, which provides guidance to applicants regarding the format and content of the non-clinical data submitted to the SFDA.
This guidance should be read in conjunction with the following:
• Data Requirements for Veterinary Medicinal Products.
• Regulatory Framework for Drugs Approval.
• Guidance for Submission.
• Saudi Law of Ethics of Research on Living Things (Royal Decree No. M /59), for products manufactured and/or studied locally.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidelines, which are implemented by SFDA:
• VICH GL6: Environmental Impact Assessment (Phase I)
• VICH GL9: Good Clinical Practice
• VICH GL38: Environmental Impact Assessment (Phase II)
• VICH GL41: Reversion to Virulence
• VICH GL44: Target Animal Safety
• VICH GL48: Metabolism and Residue Kinetics (Withdrawal period establishing)
• VICH GL49: Metabolism and Residue Kinetics (Validation of analytical method)
If no corresponding VICH guidelines are available, the SFDA takes into consideration other relevant guidelines established by the European Medicines Agency-Committee for Veterinary Medicinal Products (EMA-CVMP), either independently or in conjunction with VICH, where they provide supportive guidance. In addition, the use of pharmacopoeial vaccine monographs and associated general monographs is encouraged.
The SFDA reserves the right to request information or material not specifically described in this document to assess the safety, efficacy, or quality of a therapeutic product. Such a request would be justified and well-documented.
Active Immunological components
Refer to the antigen used in the vaccine to facilitate immunization against the antigen type; including virus, bacterium, toxin antigens, etc…
Adjuvants
Substances incorporated into or injected simultaneously with an antigen that stimulate enhanced, longer-lived immune responses (derived from the Latin adiuvare, “to help").
Applicant:
Any person or entity submitting an application to SFDA. The terms "sponsor" and "applicant" are used interchangeably within this document.
Batch/Lot:
A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits.
Field Study/ trial:
A study that aims to examine under field conditions the safety or efficacy of a veterinary medicinal product under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a Marketing Authorization or a change thereof.
Control Articles:
Refer to a comparison substance or product given to a separate group to establish a baseline for the study's results.
Duration of immunity (DOI):
Time period of protection demonstrated via challenge or serology, supporting label claims.
Investigational Veterinary Vaccine (IVV):
Any live or killed vaccines being evaluated in a clinical or non-clinical study, to investigate any protective, therapeutic, diagnostic, or physiological effect when administered or applied to an animal.
Maximum Release Potency:
The expected maximum antigen content allowed at the time of release is expressed in units appropriate for the IVV.
Maximum Release Titer:
The expected highest number of viable organisms allowed per dose in a vaccine at the time of release, verified by safety studies.
Minimum Release Potency:
The expected minimum antigen content allowed at the time of release expressed in units appropriate for the IVV.
Minimum Release Titer:
The expected lowest number of viable organisms required per dose in a vaccine at the time of release, verified by efficacy and stability studies.
Non-clinical:
Data or studies (in vivo, in vitro) aim to investigate the safety or efficacy of a veterinary medicinal product for the purpose of obtaining a marketing authorization or a change thereof.
Non-active component:
Any substances used in vaccine formulation other than active immunological components, including all excipient classes: adjuvants, stabilizers, preservatives, antibiotics, buffers, and diluents.
Reversion to virulence:
Assessment of genetic and phenotypic stability across passages in the target host.
Risk management plan (RMP):
Proportionate to product risks (live vs. inactivated, novel adjuvants), including minimization measures and pharmacovigilance commitments.
Shedding and transmission:
Evaluation of post-vaccination shedding, environmental persistence, and potential transmission to contacts.
Study Protocol:
A document that fully describes the objective(s), design, methodology, statistical considerations, and organization of a study. The document is signed and dated by the investigator for clinical studies (or study director for GLP studies) and the sponsor. The protocol may also give the background and rationale for the study, but these could be provided in other study protocol-referenced documents. The term includes all protocol amendments.
Test Articles:
Refer to Investigational Veterinary Vaccines (IVVs).
Vaccine:
Preparations that contain antigenic substances capable of inducing a specific and active immunity against the infecting agent, the toxin, or the antigen produced by it.
Every submission to SFDA is required to include certain non-clinical data to support the safety and efficacy of the veterinary vaccine. The non-clinical laboratory studies should follow GLP where applicable; target animal safety, efficacy, and field studies should follow GCP according to VICH GL9. In addition, each non-clinical study must include an approved study protocol, as well as corresponding ethical approval issued by an Institutional Animal Care and Use Committee (IACUC). For studies conducted nationally, the ethical committee should be registered with the National Committee of Bioethics (NCBE), and the committee's registration number should be provided. The required non-clinical data depend on the type of vaccine, whether it is live or inactivated, and whether targeting a food-producing animal or a non-food producing animal. Non-clinical studies should be carried out on each claimed target species, unless otherwise specified by the relevant guideline. Each study should clearly describe both qualitative and quantitative parameters of the final product used in the investigation. The batches used for these data should be produced in accordance with the manufacturing process described in Part 2 of the application dossier, and a Certificate of Analysis (COA) must be provided. State any process changes for providing a batch when applicable.
Furthermore, veterinary vaccine potency units should be assigned according to studies outcomes and the nature of the antigen. The applicant must express the dose with an appropriate unit, as outlined in Table 1 of the recommended common units. In cases where a non-standard or uncommon unit is used, the applicant must provide adequate justification supported by appropriate data.
Table 1: Common dose units expressed in veterinary vaccine
Unit
Unit Definition
Description (typical usage)
CFU
Colony forming units
Live attenuated organisms
PFU
Plaque-forming units
TCID₅₀
Tissue culture infectious dose
EID₅₀
Egg infectious dose
Antigenic mass expressions
-
Inactivated whole organisms
ELISA units
Enzyme-linked immunosorbent assay units
Inactivated whole organisms and
Subunit proteins or peptides
IU
International Units
µg
Micrograms
Subunit proteins, peptides or polysaccharide
Note that the SFDA does not accept summaries of the non-clinical data alone for all applications. The full study reports for all non-clinical data and studies conducted must be provided by the applicant (see writing guide in section 4). Justification is mandatory in all cases of deviation from the requirements, as the SFDA reserves the right to refrain from accepting the provided justification. The checklist (Appendix 1) must be completed for all registration applications and included within the General Requirements section (dossier sections 3a and 4a).
The following sections provide guidance on the minimum non-clinical data required:
A complete non-clinical safety assessment is required to establish a safety of the vaccine for target species, human exposure and environmental exposure (Table 2).
Table 2: Safety studies requirement surmised according to vaccine type:
Special Requirements for Live Vaccines
Shedding and transmission
Reversion to virulence
: should be provided
NA: not a requirement
CC: case-by-case based on risk profile, product nature, claims, and guidance.
GMO*: these products include recombinant vectors, genetically modified organisms
Safety studies should be carried out at maximum potencies. Multivalent vaccine should be tested by each active immunological component (strain/antigens), maximum potency, and worst-case combinations for local/systemic reactions per VICH GL44. Where alternative approaches are specified by the relevant guideline or product-specific monographs, the applicant provides an appropriate justification.
The safety requirements vary depending on the vaccine type, as described below:
3.1.1. Live vaccine of food-producing animals
A complete safety section (Part 3) should be provided according to SFDA Data Requirements for Veterinary Medicinal Products, as it should include the following:
1. General requirements
The applicant should provide a detailed description of the vaccine and the diseases, including the following:
• Specify the vaccine type, including product class (live attenuated, inactivated, toxoid, recombinant subunit, vector, DNA/RNA…etc.), and antigen type (virus, bacterium, toxin antigen…etc.).
• Master and working seed identity, purity, characterization (genotype/phenotype), extraneous agent testing panel; genetic stability of seed; passage history; attenuation markers of each antigen/strain.
• Epidemiological data for each disease and target animal species.
• Qualitative and quantitative parameters of the final product and copies of all COAs of each utilized batch. Manufactured under the finalized process and is representative of a commercial product; traceable to Part 2 of the dossier.
• Describe the biosafety measures implemented in the provided application.
• List of implemented laws, regulations, biosafety measures (levels), and technical references (guidelines, monographs, manuals…etc.) for each study.
• A summary for all non-active components, residual limits (e.g., aluminum, formaldehyde), and literature support, where applicable.
2. Target species safety studies
Studies should be in accordance with VICH GL44, including dose selection (single, repeat, overdose where justified), observation periods, endpoints (local/systemic reactions, temperature), and statistical analysis. Animal reproductive system safety and potential effects on performance should be assessed as indicated by claims and risk profile. Note that the SFDA is implementing Ph.Eur. 5.2.6. general monograph as a basis for study design requirements where applicable.
3. Live vaccines special requirements
Spread and dissemination studies should be provided for live vaccines. Assessing all risks, including potential non-target species susceptibility, dissemination, etc. The reversion to virulence study should be according to the VICH GL41 guideline. Note that the SFDA is implementing Ph.Eur. 5.2.6. general monograph as a basis for study design requirements where applicable.
4. User Safety
User safety should be assessed in accordance with the following principles, supported by a comprehensive literature review:
• Hazard identification and characterization
• Exposure assessment.
• Assessment of the consequences of a hazard occurring
• Risk characterization.
• Risk management (selection and assignment of appropriate control measures)
• Risk communication.
The assessment should be for overall product components, including both immunological and non-active components of the finished product. Applicants are advised to follow EMEA/CVMP/IWP/54533/2006 as the primary guideline for URA assessment. Alternative guidelines are acceptable as long as the applicant is implementing the previous principles.
5. Residues studies
Most vaccines do not require a residues study if excipients and adjuvants are pharmacologically inactive. However, a comprehensive literature review highlighting the physiochemical properties and pharmacokinetic properties of each substance for each target species should be provided. The residue of any pharmacologically active substances in each of the claimed target species should be investigated according to the VICH GL 48 guideline. The residues determination should be by an appropriate analytical method and should be validated according to the VICH GL 49 guideline.
6. Environment risks assessment (ERA)
The ERA assessment normally should be conducted in two phases:
• Phase I assessment is compulsory for all applications as it should indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure. It should be performed as recommended in the VICH GL6 guideline (EMEA/CVMP/074/95 is applicable). If the phase concluded a high-risk level of exposure potential to the environment, the applicant should proceed to phase II and evaluate the potential. Triggers for Phase II include live organisms, significant environmental exposure from shedding, and non-target species/ecosystem endpoints (soil, water, aquatics, and arthropods).
• Phase II evaluates the potential environmental risks posed by the veterinary medicinal product. Further investigations may be required to assess impacts on soil, water, air, aquatic systems, and non-target organisms, and should be carried out according to the VICH GL38 guideline.
7. Other requirements
Assessment for immunological functions, biological properties of the vaccine strain, risk of recombination or genomic reassortment of strains, interactions with other vaccines/medicines, and GMOs (e.g., recombinant vectors) data. These requirements are applicable depending on the nature of the product and existing data. As comprehensive literature review should be provided for immunological functions, biological properties of the vaccine strain, recombination or genomic reassortment of strains, and possible interactions (immunological and non-active component) for specified target species. If the provided data fail to demonstrate the required safety aspects, the product may be subject to further evaluation through appropriately designed non-clinical studies according to the relevant guidelines.
3.1.2. Inactivated vaccine of food-producing animals
A complete safety section (Part 3) should be provided as described for the live vaccine of food producing animals section. Moreover, under the general requirements, the inactivation process and validation, sterility, potency, consistency, and stability should be detailed under general requirements (3a). However, studies specific to live vaccine are not required for inactivated vaccine applications, including:
• Special requirements for live vaccines.
Other than this exception, applicants should adhere to the same requirements and guidelines outlined above.
3.1.3. Live vaccine for non-food producing animals
A complete safety section (Part 3) should be provided as described for the live vaccine of food producing animals section. However, studies specific to food producing animals are not required, including:
• Study of residues.
All other requirements and guidelines should be followed as previously outlined.
3.1.4. Inactivated vaccine for non-food producing animals
A complete safety section (Part 3) should be provided as described for the live vaccine of food producing animals section. Moreover, under the general requirements, the inactivation process and validation, sterility, potency, consistency, and stability should be detailed, under general requirements (3a). However, studies specific to food producing animals or live vaccines are not required, including:
All other requirements and guidelines should be followed as previously outlined.
Vaccines' non-clinical efficacy data assessment aims to establish immunogenicity, duration of immunity (DOI), and onset of immunity (OOI) by applicable pharmacopoeial monograph and regulatory guidelines. Other requirements might be requested according to the provided application claim and indication. Where appropriate, efficacy may be supported by validated correlates of protection and comprehensive literature, provided bridging analyses confirm product comparability and population relevance. Animal studies should follow VICH GL9; laboratory assays should be validated and, where applicable, GLP-compliant.
Efficacy studies should be demonstrated at the minimum release potency and supported at the end-of-shelf-life potency. For multivalent vaccines, each active immunological component must be evaluated at its minimum potency, including assessment of antigenic interference. Where alternative approaches are specified by the relevant guideline or product-specific monographs, the applicant provides an appropriate justification.
The efficacy requirements generally are for all vaccine types, including:
3.2.1. General requirements
• Inactivation process and validation (if applicable), sterility, potency, consistency, stability.
• Epidemiological data for each disease and target animal species. Align target strains/serotypes and challenge strains with current field epidemiology and label claims; justify geographic relevance.
• Qualitative and quantitative parameters of the final product and copies of all COAs of each utilized batch. Manufactured under the finalized process and be representative of a commercial product; traceable to Part 2 of the dossier.
3.2.2. Challenge and immunogenicity test
Immunogenicity should be established by overcoming the vaccinated target species of challenge test. The challenge study designs should predefine endpoints, controls, randomization/blinding, and statistical plans; according to reliable technical documents. Acceptable technical references include relevant pharmacopoeial monographs, World Organisation for Animal Health (WOAH) manuals, and EMA. DOI and OOI claims should be substantiated by time-point challenge or validated correlates; extrapolation solely from serology requires justification.
Miscellaneous requirements fall under safety and/or efficacy. The applicant data must comply with GLP applies to laboratory components where applicable; animal studies should adhere to GCP. The required data includes, but is not limited to, the following:
• Methods validation reports (analytical, bioanalytical, diagnostic, and serological), where they should meet validation standards (accuracy, precision, specificity, linearity, range, robustness).
• Certificate of Analysis (COAs): certificates of investigated product, control material, reference material, specific pathogen free (SPF) animals, and challenge model…etc.
• Standard operating procedures (SOPs) include: operation, methodology, mentoring, husbandry, archiving, etc.
• Raw data of individual animal results such as monitoring reports, analytical printable reports, etc.
• Other documents, such as quality assurance reports, risk management plan (RMP), and amendments to the report and/or protocol.
Additional supporting documents may be requested when necessary. The submitted technical documents should follow the relevant international guidelines (i.e., VICH) where applicable. The applicant is required to attach each document to its corresponding study report. Cross-referencing to other parts of the product dossier is acceptable where appropriate, provided that a copy of the required document is included. Applicants must ensure data integrity by maintaining version control and archiving.
Non-clinical data, written and tabulated summaries, study reports, and literature references should be written in English. Documents submitted in other languages will not be taken into consideration unless they are accompanied by an official and certified translation of the original documents. SFDA retains the right to request a retranslation at any time if the accuracy of the translation appears inaccurate or incomplete. Text and tables should be prepared using margins that allow the document to be printed on both A4 paper (E.U. and Japan) and 8.5" x 11" paper (U.S.). Font sizes for text and tables should be of a style and size that are large enough to be easily legible. Times New Roman, 12-point font, is recommended. The pagination must be carefully checked for correct sequence and completeness. Positioning of page numbers is optional. Acronyms and abbreviations should be defined the first time they are used.
Non-clinical data reports formatting should be applied to all non-clinical data documents. However, if the data are obtained by conducting an animal in vivo study, the report formatting should follow the instructions provided in section 4.3.
Reports should be submitted in Part 3 Safety documentation and Part 4 Efficacy documentation of the dossier according to the SFDA’s Data Requirements for Veterinary Medicinal Products, Content of the Dossier. Additionally, all reports should be submitted in Portable Document Format (PDF) and must fulfil the requirements of the SFDA’s Guidance for Submission. Each study should be submitted separately. If the sponsor combines multiple studies in a single file, they must include a table of contents page listing the study title, the page number, and a cross-reference to each corresponding study.
4.2.1. Title page:
The title page should include the data title, data report number, relevant dates, sponsor, quality assurance auditor, and study director, as a minimum. Additional data report identifiers (e.g., protocol number, testing facility details, principal investigators (PI) of the study, version/amendment number) should be included, where and when applicable.
4.2.2. Summary:
Provide an accurate summary of research objectives, a brief overview of the provided data “the investigational product name and detail should be clearly stated”, a summary of salient findings, a brief interpretation of the data, and conclusions.
4.2.3. Objectives:
The purpose of the data “overview, study...etc” that was conducted should be clearly stated, including the research question, research objectives, and, where appropriate, specific hypotheses being tested.
4.2.4. Report body:
This section should include all details of the experiment where applicable: design, materials and methods, statistical analysis, literature review, results, discussions, and conclusions. Additionally, the applicant should implement applicable guidelines requirements at the report body.
The applicant is requested to provide and attach copies of the cited literatures.
4.2.5. References:
A list of references used should be provided in accordance with the current edition of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, International Committee of Medical Journal Editors (ICMJE). All other references that are provided should be available upon request. Providing a list of references without in-text citations is not accepted.
4.2.6. Appendices and annex:
Both appendices and annexes may be utilized when applicable:
• Appendices are for study-generated materials. A full list of all appendices available for the study report should be provided in this section. There is no limit on what can be placed in an appendix; yet, each appendix must be labelled with appropriately (e.g. letters, Roman numerals etc.) according to where it appears in the report and must be referred to at the appropriate point in the text.
• Annex governing/external associated document. Include, but are not limited to: approved study protocols, COA (product, reagents, SPF, etc.), SOPs, and literature copies, tests validation reports, ethical approval later…etc.
This report formatting should be implemented whenever an animal in vivo study is submitted. These types of studies include, but are not limited to, the following:
• Target animal safety studies, including one-dose, repeated-dose, overdose, and reproductive performance studies.
• Special requirements for live vaccines
• Interactions studies.
• Efficacy challenge studies, including but not limited to immunogenicity, duration of immunity (DOI), and onset of immunity (OOI).
Study reports should be submitted in Part 3 Safety documentation and Part 4 Efficacy documentation of the dossier according to the SFDA’s Data Requirements for Veterinary Medicinal Products, Content of the Dossier. Additionally, approved protocol and ethical approval should be provided in the designated section.
All reports should be submitted in Portable Document Format (PDF) and must fulfil the requirements of the SFDA’s Guidance for Submission. Each study should be submitted separately. If the sponsor combines multiple studies in a single file, they must include a table of contents page listing the study title, the page number, and a cross-reference to each corresponding study.
4.3.1. Title page:
Title page should include the study title, study report number, start and end dates, as a minimum. Additional study identifiers (e.g., protocol number, testing facility details, sponsor, quality assurance auditor, study director, principal investigators (PI) of the study, version/amendment number) should be included, where applicable.
4.3.2. Summary:
Provide an accurate summary of research objectives, a brief overview of the experimental model and the methods used, a summary of salient findings, a brief interpretation of the data, and conclusions.
4.3.3. Background:
Provide sufficient scientific background that illustrates the rationale and context for the study, as well as the experimental approach. The applicant could also describe how the experimental model used addresses the scientific objectives, specifics related to the pathogen, and target species.
4.3.4. Objectives:
The purpose of the study that was conducted should be clearly stated, including the research question, research objectives, and, where appropriate, specific hypotheses being tested.
4.3.5. Study Design:
The study design includes brief details of the following:
• The groups being compared, including control groups and the exact value of the number of animals in each experimental group, if applicable. If no control group has been used, a rationale should be stated.
• The experimental unit, the exact number of experimental units allocated to each group, and the total number in each experiment.
• Information related to any inclusion and exclusion criteria for animals (or experimental units) during the experiment.
• Details related to each target species used, such as breed, sex, age or developmental stage, weight, etc.
• Information related to the provenance of animals, health/immune status, medicated or not, genetic modification status, genotype, if applicable.
• Details of blinding and randomization approaches (including: sequence generation, allocation concealment, blinding levels, checks for unblinding and mitigation)
4.3.6. Materials and Methods:
Information on the test and control articles must be included in the materials section. This should include information on articles identification name/number, batch number, physical form, composition and purity (supported by COA), storage conditions, and stability.
Methods should be described in enough detail. The presentation of the used methodology varies across different types of nonclinical studies. Some information could be generalized (such as providing an ethical approval statement where the applicant is required to provide information related to the authority granting ethics approval, approval number, and approval date, if applicable). Each study report should provide details of the following, where applicable:
• Housing and husbandry conditions (e.g., food and water, temperature and humidity, sanitation, lighting, etc.).
• Details related to test methodology and system, where applicable. Including but not limited to:
1. Type test and the purpose of the test: such as serology, diagnostic, or residual determination.
2. Type of system used: such as PCR, ELISA, HPLC …etc.
3. Reagent used for testing (reagent related documents should be provided).
4. Matrix to be tested: urine, whole blood, serum…etc.
5. Interval of testing with justifiable timing.
6. Sample preparation method.
7. Method details: such as reference method identifier, validation report identifier,
• Detailed description of each procedure used in the study.
• Description of parameters measured (units, rounding approach, etc.).
• Description of challenge model: Strain ID, passage history, dose verification, titration; shedding/reversion to virulence; interference and maternal antibody effects; DOI/OOI model justification, where applicable.
4.3.7. Statistical analysis:
Provide details of statistical methods applied, including:
• Details of the statistical methods used for each analysis, including the software used.
• Details of any methods used to assess whether the data met the assumptions of the statistical approach.
• Details of all quantitative and/or qualitative assessments that were performed.
• Details related to sample size calculation, if done (i.e., explain how the sample size was decided)
• How missing values were handled.
• If data transformation was performed, the transformation used and a rationale for the choice of data transformation should be provided.
• Any other information that helps the evaluators assess the submitted studies.
4.3.8. Results:
Characteristics of all animals used (such as species, breed sex, weight, and age) should be reported. As indicated above, the analyses could include quantitative and/or qualitative assessments. Therefore, each type of analysis could be presented differently, yet the data presented should be unambiguous, concise, and clear to the evaluators.
As an example, for quantitative analyses, for each experiment conducted, the sponsor should provide the following (where applicable):
• Fundamental statistical and numerical descriptions (such as significant digits, error, and correlations).
• Summary/descriptive statistics for each experimental group. For continuous data, a measure of central tendency (e.g., mean, median) and a measure of variability (e.g., quartiles, range, standard deviation) must be included. Categorical data can be expressed as counts, frequencies, or proportions.
• Statistical significance level (i.e., p-value) should be reported, in addition to the effect size with a confidence interval (if applicable).
Data could also be presented in tables or in figures to enable information to be evaluated. The applicant should report the results of all analyses performed, even the non-statistically significant ones.
4.3.9. Discussions and Conclusions:
In this section, the results should be interpreted, and the significance of the findings should be discussed in light of the objective(s) of the study. The strengths and limitations of the research can also be discussed. The conclusion should clearly highlight the key findings and important outcomes of the study.
4.3.10. Literature References:
A list of references used should be provided in accordance with the current edition of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, International Committee of Medical Journal Editors (ICMJE). The applicant is requested to provide and attach copies of cited literatures. All other references that are provided should be available upon request. Providing a list of references without in-text citations is not accepted.
4.3.11. Appendices and annex:
• Appendices are for study-generated materials. A full list of all appendices available for the study report should be provided in this section. There is no limit on what can be placed in an appendix; yet, each appendix must be labelled appropriately (e.g., letters, Roman numerals, etc.) according to where it appears in the report and must be referred to at the appropriate point in the text
• Annex governing/external associated document. Include, but are not limited to: approved study protocols, COA (product, reagents, SPF, etc.), SOPs, and literatures copies, tests validation reports, ethical approval later…etc.
Last update: 14 July 2026
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