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Search for "Post-market Surveillance" related English Translations
29 results found
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Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (2018.12.30)
Dec 04, 2018
EN
This document is the order for enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. The Cabinet hereby enacts this Cabinet Order pursuant to the provisions of Article 2, paragraph (4), Article 11 (including as applied mutatis mutandis pursuant to Article 38), Article 28, paragraph (2), Article 30, paragraph (3), Article 43, paragraph (2), Article 67, paragraph (1), Article 77, paragraph (3), Article 78, paragraph (1), Article 80 and Article 82 of the Pharmaceutical Affairs Act (Act No. 145 of 1960). Note: This translation was published by Japanese Law Translation and is an unofficial text. The translation is only updated to the 2015 revision while the revised edition of 2016 is in effect. This document should only be used as a reference for understanding Japanese regulations and in case of any discrepancy between the English and Japanese versions the original Japanese version shall prevail.
Japan
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
Manufacturer/Importer Regulation
Enforcement Rules of Cosmetic Hygiene and Safety Act
Jul 18, 2019
EN
The Enforcement Rules specify the definition of cosmetic country of origin and manufacturing site and conditions of the claim or advertising violation, etc. and give clear details of the compliance requirements for manufacturer and importer.These Enforcement Rules shall come into force on July 1, 2019, with the exception of Article 3 and Paragraph 2 of Article 4, which shall come into force on July 1, 2021.
Taiwan, China
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
Manufacturer/Importer Regulation
Advertising
Interim Provisions on the Administration of Cosmetics Overseas Inspection (Draft)
Nov 26, 2019
EN
The draft regulations specify details on overseas cosmetic inspection procedures, including inspection scope, the competent authority, results, and penalties for violation of the regulation.
Chinese Mainland
Post-market Surveillance
Enterprise Obligations
Regulations for Cosmetic Product Information File Management
Jul 19, 2019
EN
The regulation specifies information about how to build product information file(PIF), including qualifications of the manufacturer and importer who can establish the PIF, documents required for PIF, the time PIF should be kept, the qualifications for product safety data signers, etc.
Taiwan, China
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Post-market Surveillance
Manufacturer/Importer Regulation
Safety Assessment
Testing
Regulations Governing the Source and the Flow Data of Cosmetic Products
Jul 19, 2019
EN
The Measures specify the scope, items and contents of information on direct supply sources and supply chain flows established by cosmetics manufacturers, importers and dealers.
Taiwan, China
Post-market Surveillance
Regulations for Cosmetics Recall
Jul 22, 2019
EN
The main contents of Regulations for Cosmetic Recall include:Legal basisCosmetics recall levelThe time limit for first, second and third level cosmetic recallWhen municipal or county competent authorities recall cosmetics, they shall notify TFDA and other counties or cities, as well as disclose recalled cosmetics information to the publicManufacturers or importers shall establish cosmetics recall proceduresManufacturers or importers shall notify distributors to recall products within 7 days of receiving notification from the competent authority. For first-level recalled cosmetics, shall notify distributors within 3 daysManufacturers or importers shall submit a recall plan to the competent authority within 14 days of receiving a notification. For the first level recalled cosmetics, within 7 daysTemporary storage method of recalled productsManufacturers or importers shall submit a product recall report to the competent authority after completing the recallAfter receiving the product recall report, the competent authority should conduct on-site inspections
Taiwan, China
Post-market Surveillance
Regulations for Reporting Cosmetics Serious Adverse Effects and Hazards to Hygiene and Safety
Jul 22, 2019
EN
The regulation stipulates the target to notify, the method and content of adverse event notification. If severe adverse events occur or the product is found to be harmful to human health, it shall be notified on the online system established by the central competent authority within 15 days (in an emergency, manufacturers can notify it verbally). The credentials, dossiers or data shall be kept for at least 5 years.
Taiwan, China
Pre-market Approval
Post-market Surveillance
Enforcement Decree of the Cosmetics Act (Presidential Decree No.32445, Feb. 15, 2022)
Nov 25, 2019
EN&KR
The purpose of this decree is to prescribe matters delegated by the Cosmetics Act and other matters necessary for the enforcement.This regulation includes:Detailed types and scope of businessStandards for calculation of penalty surchargeProcedures for imposition and collection of penalty surchargesDisposition against payer in arrears of penalty surchargePublication of relevant violationsDelegation of authority, treatment of sensitive information and unique identifiable informationStandards for imposition of administrative finesEnforcement date
South Korea
Pre-market Approval
Post-market Surveillance
Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices (Draft for Comments)
Apr 11, 2022
EN
On January 7, 2022, China NMPA issued the finalized Good Manufacturing Practices for Cosmetics and will implement it on July 1, 2022. Cosmetics registrants, notifiers, and entrusted production enterprises shall organize the cosmetic production in accordance with the Practices. Following that, on March 30, 2022, NMPA released the draft of Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices (hereinafter referred to as “Points”) for public consultation. Regulatory authorities across China will use the Points as a basis to determine whether the enterprise complies with GMP. Any suggestions about the Points can be mailed to NMPA (hzpjgc@nmpa.gov.cn) before April 20, 2022.The Points is an upgraded version of Practice for Cosmetics Production Licensing implemented in 2016, with more stringent inspection requirements. The expected effective date of the Points is July 1, 2022, which is the same as that of Good Manufacturing Practices for Cosmetics.Main ContentsThere are a total of 106 articles in the Points, and separate inspection points are set for the manufacturing and entrusting enterprises.1. Applicable Scope2. Inspection Classification and Judgment Principles3. Other MattersAnnex I Inspection Points for Cosmetic Good Manufacturing Practices (For Manufacturing Enterprises)Annex II Inspection Points for Cosmetic Good Manufacturing Practices (For Entrusting Enterprises)
Chinese Mainland
Post-market Surveillance
GMP
CSAR
Enterprise Obligations
Pre
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