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Therapeutic areas / Dermatology

Dermatology Regulatory Updates

55 guidances, approvals and safety alerts affecting dermatology, collected from official agency sources. Showing the 30 most recent.

EMA (EU) · 9
WHO · 3
CDSCO (India) · 8
Swissmedic · 2
MFDS (South Korea) · 3
FDA (CDER) · 3
TITCK (Turkey) · 2
Upcoming Event (4d)
EVENT
Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 October 2026
EMA (EU) • Scheduled: Oct 6, 2026 (in 4 days)

CVMP is scheduled to meet on 6–8 October 2026 to prepare the European Medicines Agency’s opinions on veterinary medicines-related questions.

infectious_disease
oncology
+11
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SAFETY ALERT
Webinar: Launch of WHO’s prequalification procedure for medical devices – 25 September 2026
WHO • Published: Oct 2, 2026

Launches WHO’s prequalification procedure for medical devices, signposting a new pathway for manufacturers to seek WHO endorsement and broader market access.

infectious_disease
pediatrics
+11
View update →
REGULATORY UPDATE
WHO PQT launches eCTD submissions through the ePQS Portal
WHO • Published: Oct 2, 2026

Launches WHO PQT eCTD submission capability via the ePQS Portal, enabling a harmonized electronic format to improve dossier lifecycle management and streamline…

infectious_disease
oncology
+16
View update →
REGULATORY UPDATE
Updated guidance on plain language descriptions of visual appearance for oral dosage forms in WHOPARs
WHO • Published: Oct 2, 2026

Clarifies WHO prequalification expectations for plain-language descriptions of the visual appearance of oral dosage forms in WHOPARs, improving consistency and…

infectious_disease
oncology
+16
View update →
EVENT
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - September 2026
EMA (EU) • Published: Sep 23, 2026

Convenes the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to coordinate oversight actions related to medicines shortages…

infectious_disease
rare_diseases
+11
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GUIDANCE FINAL
Draft guideline on user safety of topically administered veterinary medicinal products - Revision 1
EMA (EU) • Published: Sep 18, 2026

Clarifies how applicants should conduct user risk assessments for topically administered veterinary medicinal products, including hazard identification, dermal…

safety
dermatology
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GUIDANCE FINAL
Draft reflection paper on the clinical investigation of medicinal products for the treatment of systemic sclerosis
EMA (EU) • Published: Sep 18, 2026

Provides a CHMP reflection framework for sponsors planning clinical development of medicinal products intended for systemic sclerosis, with particular emphasis…

immunology
rare_diseases
+6
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EVENT
Fifth European Medicines Agency (EMA) and Affordable Medicines Europe bilateral meeting
EMA (EU) • Published: Sep 11, 2026

Facilitates a structured dialogue between EMA and Affordable Medicines Europe to exchange views on topics of common interest within EMA’s annual bilateral…

infectious_disease
rare_diseases
+16
View update →
EVENT
Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 September 2026
EMA (EU) • Published: Sep 10, 2026

Schedules the CVMP meeting for 8–10 September 2026, enabling stakeholders to track committee deliberations and expected scientific opinions or guidance-related…

infectious_disease
immunology
+4
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REGULATION
2026.09.03 G.S.R. 790(E)_Draft Notification for extension of prior intimation system for certain BA and BE studies for approval of New Drugs in India
CDSCO (India) • Published: Sep 3, 2026

Extends the use of a prior intimation mechanism for specified bioavailability (BA) and bioequivalence (BE) studies submitted to CDSCO as part of approval of…

clinical
safety
+16
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REGULATORY UPDATE
Simplification of applications for a change of status between main authorisation and export licence for veterinary medicinal products
Swissmedic • Published: Sep 1, 2026

Simplifies Swissmedic application procedures for changing a veterinary medicinal product’s status between its main authorisation and an export licence.

infectious_disease
oncology
+16
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NOTICE
「의약품 등의 안전에 관한 규칙」 일부개정령(안) 입법예고(식품의약품안전처 공고 제2026-412호)
MFDS (South Korea) • Published: Aug 21, 2026

Introduces a draft amendment notice for Korea’s MFDS regulations on the safety of pharmaceuticals and related products.

infectious_disease
rare_diseases
+16
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GUIDANCE FINAL
Evaluation of Therapeutic Equivalence
FDA (CDER) • Published: Aug 21, 2026

Clarifies FDA expectations for demonstrating therapeutic equivalence for approved drug products, with emphasis on the evidentiary basis used to support…

clinical
manufacturing
+16
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NOTICE
화장품 표시·광고 실증에 관한 규정 일부개정고시안
MFDS (South Korea) • Published: Aug 18, 2026

Drafts partial amendments to Korea’s regulations governing how evidence is substantiated and presented for cosmetic product labeling and advertising.

dermatology
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NOTICE
기능성화장품 심사에 관한 규정 일부개정고시안
MFDS (South Korea) • Published: Aug 18, 2026

Functional cosmetics review rules are partially amended to update the assessment and review requirements applied by MFDS.

dermatology
safety
+3
View update →
NOTICE
Guidance Document on Common Submission Format for Import & Registration of Drug(s) (Bulk & Finished Formulations) in India
CDSCO (India) • Published: Aug 5, 2026

Common Submission Format guidance for importing and registering drugs (bulk and finished formulations) in India is intended to standardize how dossiers are…

infectious_disease
pediatrics
+16
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NOTICE
Vigilance on imported cosmetics products sold in the domestic market without valid lmport Registration certificate
CDSCO (India) • Published: Jul 23, 2026

Targets enforcement and vigilance actions against imported cosmetics that are marketed in India without a valid import registration certificate.

dermatology
View update →
REGULATION
2026.06.11 S.O. 3068(E) to S.O. 3083(E)_ Prohibition of 16 FDCs
CDSCO (India) • Published: Jul 21, 2026

Prohibits the marketing/approval of 16 fixed-dose combinations (FDCs) under specified Gazette notifications, potentially affecting existing and pending…

manufacturing
quality
+16
View update →
GUIDANCE FINAL
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
FDA (CDER) • Published: Jul 14, 2026

Clarifies FDA expectations for demonstrating in vivo bioequivalence for topical dermatologic corticosteroid products, which may affect study design, bridging…

dermatology
clinical
View update →
NOTICE
KOZMETİK ÜRÜNLERE İLİŞKİN 2026 YILI İKİNCİ ÜÇ AYLIK DÖNEM DENETİM VERİLERİ - 5322
TITCK (Turkey) • Published: Jul 10, 2026

Publishes inspection data for cosmetic products for the second quarterly period of 2026 (covering 01/04/2026–30/06/2026).

dermatology
manufacturing
+3
View update →
EVENT
20th anniversary of European Medicines Agency's Patients' and Consumers' Working Party (PCWP)
EMA (EU) • Published: Jun 30, 2026

Highlights the 20-year evolution of EMA’s Patients’ and Consumers’ Working Party (PCWP) from a patient organisations working group (2003) to an EMA-endorsed…

immunology
oncology
+16
View update →
GUIDANCE DRAFT
Master Protocols for Drug and Biological Product Development
FDA (CDER) • Published: Jun 24, 2026

Outlines a draft master protocol framework for coordinating and managing multiple clinical studies supporting drug and biological product development…

immunology
oncology
+16
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NOTICE
Kozmetik Firmalarının Dikkatine - 5310
TITCK (Turkey) • Published: Jun 23, 2026

Announcement directed to cosmetic firms (Kozmetik Firmaları) indicating a regulatory “notice” with unspecified compliance actions.

dermatology
manufacturing
+3
View update →
REGULATION
2026.06.23 G.S.R. 509(E)_ Draft notification regarding simplification of the process for obtaining test licences for import of drugs under Form 11 of the Drugs Rules, 1945
CDSCO (India) • Published: Jun 23, 2026

Simplifies the process for obtaining test licences for the import of drugs under Form 11 of the Drugs Rules, 1945, which may reduce administrative burden and…

infectious_disease
oncology
+11
View update →
EVENT
Committee for Medicinal Products for Human Use (CHMP): 22-25 June 2026
EMA (EU) • Published: Jun 22, 2026

Plans the next CHMP meeting session (22–25 June 2026) at the European Medicines Agency in Amsterdam, where CHMP will prepare agency opinions on matters…

manufacturing
quality
+16
View update →
REGULATION
2026.06.22 G.S.R. 505(E)_Draft notification regarding rationalization of shelf life under Rule 31 of Drugs Rules, 1945
CDSCO (India) • Published: Jun 22, 2026

Draft CDSCO notification rationalizes how shelf life is set under Rule 31 of the Drugs Rules, 1945, potentially changing the expectations for stability…

infectious_disease
oncology
+16
View update →
REGULATORY UPDATE
SEND datasets for new authorisation applications for human medicinal products with new active substances
Swissmedic • Published: Jun 15, 2026

Defines expectations for the SEND (Standard for Exchange of Nonclinical Data) datasets to be submitted with new authorisation applications for human medicinal…

manufacturing
quality
+16
View update →
NOTICE
Submission of Compliance for lmported/manufactured Hair Color Cosmetics Products as per Cosmetics Rules, 2020 and applicable BIS Standards
CDSCO (India) • Published: Jun 11, 2026

Specifies that compliance submissions for imported or manufactured hair color cosmetics must align with the Cosmetics Rules, 2020 and any applicable Bureau of…

dermatology
manufacturing
+3
View update →
NOTICE
Use of Cosmetics
CDSCO (India) • Published: May 19, 2026

Provides an informational/administrative notification on the regulatory use of cosmetics under CDSCO, but the supplied text contains no operative requirements…

dermatology
View update →
EVENT
Committee for Herbal Medicinal Products (HMPC): 4-6 May 2026
EMA (EU) • Published: May 11, 2026

Committee for Herbal Medicinal Products (HMPC) meeting 4–6 May 2026 will compile and publish HMPC opinions and related outputs for questions on herbal…

manufacturing
quality
+16
View update →

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