We list here guidelines pharmaceutical manufacturing issued by regulatory agencies worldwide.. You can read full guidance document by clicking on the title.
Guidance Documents Published in 2026
| Agency |
Guidance Title |
Date |
| FDA |
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs |
03/08/2026 |
| FDA |
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs |
14/07/2026 |
| CDSCO |
Guidance document on Medical Device Software under MDR-2017 |
21/07/2026 |
| FDA |
Psychedelic Drugs: Considerations for Clinical Investigations |
14/07/2026 |
| FDA |
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence |
14/07/2026 |
| ICH
|
ICH E6(R3): Good Clinical Practice Annex 2 Adopted and Published
|
10/07/2026
|
| FDA |
Submitting Next-Generation Sequencing Data to the Division of Antiviral Products |
01/07/2026 |
| FDA |
Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug |
18/06/2026 |
| FDA |
Certain Postapproval Requirements and Resources for ANDAs |
04/06/2026 |
| FDA |
M15 General Principles for Model-Informed Drug Development |
03/06/2026 |
| FDA |
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application |
29/05/2026 |
| FDA |
Q8, Q9, and Q10 Questions and Answers (R5) |
29/05/2026 |
| FDA |
Statistical Approaches to Establishing Bioequivalence |
29/05/2026 |
| FDA |
M11 Clinical Electronic Structured Harmonised Protocol |
21/05/2026 |
| FDA |
Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention |
08/05/2026 |
| FDA |
Postapproval Pregnancy Safety Studies |
08/05/2026 |
| FDA |
Pulmonary Tuberculosis: Developing Drugs for Treatment |
08/05/2026 |
| FDA |
Submitting Continuous Glucose Monitoring Data in Clinical Trials |
07/05/2026 |
| FDA
|
Bioanalytical Method Validation for Biomarkers
|
10/04/2026
|
| CDSCO
|
Manufacturing and marketing of unapproved drug product Sodium Hyaluronate Eye Drops 0.3% w/v
|
18/03/2026
|
| FDA
|
Pyrogen and Endotoxins Testing: Questions and Answers: Guidance for Industry
|
18/03/2026
|
| CDSCO
|
Guidance document on dossier based licensing of Drugs for uniform product licensing in the country
|
17/03/2026
|
| CDSCO
|
Advisory to all manufacturers, importers and marketing authorization holders
|
11/03/2026
|
| CDSCO
|
Testing Laboratories approved by Statas&UT in Form 37 of Drugs Rule 1945 and Cos 23 of Cosmetics Rule 2020
|
10/03/2026
|
| ICH
|
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
|
03/03/2026
|
| ICH
|
M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines
|
03/03/2026
|
| CDSCO
|
Doxycycline related CNS Side Effects (Restlessness, Anxiety, Irritability, Nervousness, and Dizziness) - Recommendations for the change in Prescribing Information Leaflets (PILs)
|
17/02/2026
|
| CDSCO
|
Risk classification list of medical devices pertaining to Oncology
|
02/01/2026
|
Guidance Documents Published in 2025
Guidance Documents Published in 2024
