Medical Writing
Standards reference
Look up standard names, version years and section references by document purpose. Reporting guidelines, technical guidelines and regulations have different scopes and are not interchangeable.
This page provides reference entry points for document writing and review. Project versions must be selected according to the target region, study design, submission date and journal or conference requirements. Publication, adoption and effective dates are checked separately.
Checked: 13 October 2026.
01Medical Writing
Research publications and search reports
Choose reporting checklists by study design; check author responsibilities and disclosure of involvement separately against publication standards.
| Standard and version year | Applicable documents · Section references · Source |
|---|---|
| R01International Committee of Medical Journal Editors, Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (ICMJE Recommendations, updated January 2026) | Manuscripts, author contributions and acknowledgements Section II.A.2 sets out authorship criteria; section II.A.3 covers non-author contributors. Authorship is judged by actual contributions and responsibilities; writing support and funding are disclosed truthfully. |
| R02Good Publication Practice 2022 (GPP 2022); the official Chinese translation is titled Good Publication Practice for Company-Sponsored Biomedical Research: 2022 Update | Publication plans and materials for company-funded research Supplementary material section E: publication planning; section G: determining authorship and contributions; supplementary table 4: professional writing support and disclosure in author agreements. This entry uses the Chinese translation provided by the association. The original article DOI is 10.7326/M22-1460. |
| R03Consolidated Standards of Reporting Trials (CONSORT 2025) | Randomised controlled trial papers Item 14: outcome measurement variables, analysis metrics, aggregation methods and time points; item 26: numbers analysed, results and estimation precision; item 28: other analyses and the distinction between prespecified and post hoc analyses. |
| R04Strengthening the Reporting of Observational Studies in Epidemiology (STROBE, 2007) | Cohort, case-control and cross-sectional study papers Items 7–9: variables, data sources and measurement, and bias; item 12: statistical methods; items 19–21: limitations, interpretation and generalisability. Select the checklist for the study design. |
| R05Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020; statement published in 2021) | Systematic reviews and meta-analyses Items 6 and 7: information sources and full search strategies; item 8: study selection process; items 16a and 16b: screening results and reasons for exclusion. |
| R06PRISMA extension for reporting literature searches (PRISMA-S, 2021) | Search reports and search appendices for systematic reviews Item 1: databases and platforms; item 8: full search strategies; item 13: search dates; item 16: deduplication methods. |
02Medical Writing
Clinical development and regulatory affairs
Technical guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable requirements in the target region must be checked separately. Document structure, delegation of activities and submission responsibilities are identified separately; technical guidelines do not constitute regulatory credentials for our company.
| Standard and version year | Applicable documents · Section references · Source |
|---|---|
| R08ICH E3，Structure and Content of Clinical Study Reports（1995） | Clinical study reports and safety event narratives (CSR) Chapters 1–16 set out the report structure; section 12.3.2 covers narratives of deaths, other serious adverse events and other significant adverse events. |
| R09ICH E6(R3), Good Clinical Practice (principles and Annex 1: 2025; Annex 2: 2026; consolidated corrected text, June 2026) | Investigator's brochures (IB), clinical trial protocols, informed consent and allocation of responsibilities Appendix A: IB; Appendix B: clinical trial protocols; Annex 1, section 2.8: informed consent; Annex 1, section 3.6.6: transfer of activities and the sponsor's ultimate responsibility. |
| R10ICH M4E(R2)，Common Technical Document for the Registration of Pharmaceuticals for Human Use: Efficacy（2016） | Common technical document (CTD) clinical documents Section 2.5: clinical overview; section 2.7: clinical summary. Their organisational and analytical purposes differ; document length does not replace content requirements. |
| R11Measures for the Administration of Drug Registration (药品注册管理办法) (State Administration for Market Regulation Order No. 27, 2020) | Allocation of registration application responsibilities and inspection of entrusted work Article nine: the responsible applicant entity; article forty-five: registration inspections and, where necessary, extended inspections of other entrusted institutions. |
ICH E6(R3) Annex 2 reached ICH Step 4 in 2026. The European Medicines Agency's consolidated text lists 23 July 2025 as the effective date for the principles and Annex 1, and 15 January 2027 for Annex 2. As of this page's verification date, the latter was not yet effective in that region. Adoption and implementation dates in other regions must be checked separately.
03Medical Writing
Drug safety
Check reporting intervals, data lock points and report content separately; writing documents does not mean assuming pharmacovigilance responsibility.
| Standard and version year | Applicable documents · Section references · Source |
|---|---|
| R14ICH E2C(R2), Periodic Benefit-Risk Evaluation Report (corrected version, December 2012) | Periodic benefit-risk evaluation report (PBRER) Section 2.8: reporting frequency and data lock point; section 3: report content; sections 3.16–3.18: risk, benefit and integrated benefit-risk analyses. |
| R15ICH E2F，Development Safety Update Report（2010） | Development safety update report (DSUR) Section 2.2: annual period and data lock point; section 2.4: responsibilities for preparation and submission; section 3: report content. |
| R16ICH E2E，Pharmacovigilance Planning（2004） | Safety specification and pharmacovigilance plan Section 2: safety specification; section 3: pharmacovigilance plan. E2E alone does not replace regional requirements for a complete risk management plan. |
| R17EU Good Pharmacovigilance Practices (EU GVP), Module V – Risk management systems, Rev.2 (2017) | EU risk management plan (RMP) Section V.B.3: overall structure; section V.B.5: safety specification; section V.B.6: pharmacovigilance plan. |
| R18EU GVP，Module IX – Signal management，Rev.1（2017） | Signal assessment documents Section IX.B: signal management structure and processes; specific report content is determined by the stage of the signal. |
04Medical Writing
Health economics
Assess reporting completeness and methodological suitability separately for economic evaluations; select a separate methodological basis for budget impact analyses.
| Standard and version year | Applicable documents · Section references · Source |
|---|---|
| R19Health economic evaluation reporting standards (CHEERS 2022), Consolidated Health Economic Evaluation Reporting Standards 2022 | Health economic evaluation reports and papers A 28-item reporting checklist; items 8–10 cover perspective, time horizon and discounting. It supports reporting transparency and is not a methodological quality scoring tool. Budget impact analysis is outside the statement's scope. |
05Medical Writing
Medical device clinical evaluation
Distinguish regulatory requirements, methodological guidance, manufacturer documents and notified body assessment templates.
| Standard and version year | Applicable documents · Section references · Source |
|---|---|
| R21MEDDEV 2.7/1 revision 4, Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC (June 2016) | Reference for CER methods and structure Sections 7–11 cover scope, data identification, appraisal, analysis and reporting; Appendix A9 provides a report format reference. It is based on the former directives and does not replace the MDR. |
| R22Medical Device Coordination Group (MDCG) 2020-13, Clinical Evaluation Assessment Report Template (July 2020) | Notified body clinical evaluation assessment report Part D: clinical literature review; part E: clinical investigations and related documents; part F: post-market surveillance, PMCF and update plans. This is a notified body assessment template, not a manufacturer's CER template. |
| R23MDCG 2020-7, PMCF Plan Template; MDCG 2020-8, PMCF Evaluation Report Template (both April 2020) | PMCF plans and PMCF evaluation reports Both have sections A–G. In the plan, section C covers activities and methods, and section G the expected report date. In the evaluation report, section C covers activity results, section E the impact on technical documentation, and section G the conclusions. |
| R24MDCG 2019-9 Rev.1, Summary of Safety and Clinical Performance (revised March 2022) | SSCP Section 2 of the main text: intended purpose, indications, contraindications and target populations; the annex provides a summary template. The document distinguishes information for professionals from information for patients where applicable, and does not replace the device's instructions for use. |
06Medical Writing
Versions and scope of use
References to standards must retain the name, version or year, and section reference. When standards change, check document templates, reporting checklists and in-text references together. The applicable version for a project must be confirmed against the target region and submission requirements.
Public standards explain how documents should be organised and reported. They do not demonstrate that a supplier holds particular qualifications, has completed related projects or can guarantee regulatory review or publication outcomes.
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This section describes our services. It does not concern any specific medicinal product and does not constitute drug advertising. The timelines, quality control and issue resolution processes described are our standard operating approach; the final scope, timelines, prices and obligations of each party are governed by the signed contract.
Our contribution is disclosed in the acknowledgements in line with ICMJE and GPP 2022; we are not listed as authors. For writing and statistical support for research publications, involvement and funding sources are disclosed truthfully under the International Committee of Medical Journal Editors recommendations and Good Publication Practice 2022. We do not promise publication outcomes.