Quality of transdermal patches - Scientific guideline
HumanScientific guidelines
This document provides guidance on the general requirements concerning the development and quality of transdermal patches for systemic delivery. It covers both new marketing authorisation applications and variations. In addition, it provides specific guidance concerning the data requirements to support generic or abridged applications.
Keywords: Transdermal patch, adhesives, dissolution, skin permeation
Current effective version
Guideline on quality of transdermal patches
AdoptedReference Number: EMA/CHMP/QWP/608924/2014Summary:
This guideline addresses new marketing authorisation applications (including generic or abridged applications) and subsequent variation submissions for transdermal patches for systemic delivery.
English (EN) (241.59 KB - PDF)
First published: Last updated:
Document history
Guideline on quality of transdermal patches
AdoptedReference Number: EMA/CHMP/QWP/608924/2014Summary:
This guideline addresses new marketing authorisation applications (including generic or abridged applications) and subsequent variation submissions for transdermal patches for systemic delivery.
English (EN) (241.59 KB - PDF)
First published: Last updated:
Overview of comments received on 'Draft guideline on quality of transdermal patches'
Reference Number: EMA/CHMP/QWP/608923/2014Summary:
Interested parties (organisations or individuals) that commented on the draft document as released for consultation.
English (EN) (1.25 MB - PDF)
First published: Last updated:
Draft guideline on quality of transdermal patches
Consultation dates:
to Draft: consultation closedReference Number: EMA/CHMP/QWP/911254/2011Summary:
This guideline, together with the new guideline on quality of oral modified-release products, replaces the note for guidance on modified-release products: A: oral dosage forms B: transdermal dosage forms: part I (quality).
English (EN) (241.26 KB - PDF)
First published: Last updated:
Concept paper on the revision of the note for guidance on quality of modified release oral dosage forms and transdermal dosage forms: Section I (quality) - Superseded
Consultation dates:
to Draft: consultation closedReference Number: EMA/CHMP/QWP/202350/2010
English (EN) (94.71 KB - PDF)
First published: Last updated:
Note for guidance on quality of modified release products: A: oral dosage formsB: transdermal dosage forms section I (quality) - Superseded
AdoptedLegal effective date: Reference Number: CPMP/QWP/604/96
English (EN) (83.82 KB - PDF)
First published: Last updated:
Related content
- Quality: specific types of products
- Directive 2001/83/EC
- Directive 2001/82/EC
- Details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures.
- Excipients in the dossier for application for marketing authorisation of a medicinal product
- ICH Q1A (R2) Stability testing of new drug substances and drug products
- ICH Q1C Stability testing: requirements for new dosage forms
- ICH Q2(R1) Validation of analytical procedures: text and methodology
- ICH Q6A Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances
- ICH Q8 (R2) Pharmaceutical development
- Manufacture of the finished dosage form
- Pharmacokinetic and clinical evaluation of modified-release dosage forms
- Process validation for finished products – information and data to be provided in regulatory submissions
- Stability testing of existing active ingredients and related finished products
- Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form)