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NEWS
Philippines FDA Proposes New Requirements for LTO Application
Mar 04, 2024
On February 27, 2024, Philippines FDA initiated a consultation on newly proposed amendments to LTO application requirements. Compared to previous draft amendments, the new draft primarily updates the requirements and validities for LTO applications, and further clarifies FDA’s decision grounds for these applications.
Philippines
Pre-market Approval
NEWS
Malaysia Amends Cosmetic Ingredient Use Requirements: 17 Ingredients Added and 12 Ingredients Revised
Jan 25, 2024
The amendments are: 1) Annex II: List of Prohibited Ingredients - 15 added and 4 revised 2) Annex III: List of Restricted Ingredients - 5 revised 3) Annex IV: List of Permitted Colorants – 1 revised 4) Annex VI: List of Permitted Preservatives - 1 deleted 5) Annex VII: List of Permitted UV Filters – 2 added and 1 revised
Malaysia
Ingredients
NEWS
Philippines Consults on Cosmetics Recall Guidelines
Dec 29, 2023
On December 22, 2023, Philippines FDA released a draft of Guidelines on the Recall of Health Products Regulated by the Food and Drug Administration. This Guidelines is drafted to develop an updated framework for the recall of health products, including cosmetics, in pursuit of public health and safety.
Philippines
Post-market Surveillance
NEWS
Malaysia Amends Cosmetic Ingredient Use Requirements: 19 Prohibited Ingredients Added and 5 Ingredients Revised
Jul 06, 2023
On July 4, 2023, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 2/2023 Information on the Updated Status of Ingredients in the Annexe of the Guidelines for Control of Cosmetic Products in Malaysia. According to the Circular, 19 prohibited ingredients and 2 restricted ingredients are added; 1 restricted ingredient, 1 permitted preservative and 1 permitted UV filter are revised.
Malaysia
Ingredients
NEWS
Philippines Launches a New Round of Consultation on Amended Requirements for LTO Application
Jun 12, 2023
On June 5, 2023, Philippines Food and Drug Administration (FDA) released a new draft of Updated Guidelines on the Application for License to Operate of Health Product Establishments with the Food and Drug Administration (the Updated Guidelines). Compared with two previous drafts, the newly released amendment introduces stricter guidelines for initial, renewal and variation applications for the LTO, detailing the circumstances under which the LTO may be cancelled, and strengthens the requirements for the Qualified Person.
Philippines
Pre-market Approval
Enterprise Obligations
NEWS
Malaysia Amends Cosmetic Ingredient Use Requirements: 42 Prohibited Ingredients Added and 3 Ingredients Revised
Feb 22, 2023
The main amendments include: 1) Annexe II: List of Prohibited Ingredients – 42 added 2) Annexe IV: List of Permitted Colorants – 1 revised 3) Annexe VI: List of Permitted Preservatives – 1 revised 4) Annexe VII: List of Permitted UV Filters – 1 revised
Malaysia
Ingredients
NEWS
[Updated] Philippines to Impose New Requirements on the PIF Audit for Cosmetic Products
Feb 01, 2023
Compared to the Circular No. 2018-001 currently in force, the Updated Guidelines adopts proper classification to present the previously included guidelines in a more clear and logical manner, and provides important supplements to PIF Audit.
Philippines
Post-market Surveillance
NEWS
[Updated] Philippines to Modify the Requirements for Licensing and Inspection of Health Products, Cosmetics Included
Oct 13, 2022
On May 27, 2022, Philippines FDA issued a draft of Updated Guidelines on licensing and inspection of health products. Compared to its predecessor, AO No. 2020-0017, the Updated Guidelines further clarifies the qualification for the qualified person, supplements requirements for LTO application, and devises a more comprehensive plan to regulate inspection.
Philippines
Pre-market Approval
Enterprise Obligations
NEWS
Malaysia Amends Guidelines for Control of Cosmetic Products
Jul 26, 2022
The main amendments are 1) Adding product examples classified as cosmetics and not classified as cosmetics, requirements for product complaints, as well as 3 guidance for hand sanitizers, antibacterial hygiene products, and product reporting and recall; 2) Revising and clarifying requirements for cosmetic notification, GMP inspection, GMP certificate, as well as cosmetic naming, labeling, claiming, and advertising.
Malaysia
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
GMP
NEWS
Malaysia NPRA Adopts Six Changes to Cosmetic Ingredient Use Requirements
Jul 07, 2022
Malaysia adopted six changes to cosmetic ingredient use requirements, including: 1) Adding one prohibited ingredient, one restricted ingredient and one permitted preservative; 2) Amending the use requirements of two restricted ingredients and one permitted preservative.
Malaysia
Ingredients
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MOST POPULAR
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[Updated] EU Adopts 11 Changes to the Use Requirements for Cosmetic Ingredients
2
[Updated] EU Finalizes Amendments to Use Restrictions on D4, D5, D6 in Cosmetics
3
China Consults on Guidelines for Submission of Cosmetic Safety Assessment Dossiers: Exemptions for Two Types of Cosmetics from Safety Assessment Report Submission
4
[Updated] Taiwan Amends the List of Prohibited Ingredients in Cosmetics
5
[Updated] China Expands Recognized Ingredient Safety Data for Safety Assessment Report
Featured
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Stay Current: China’s Cosmetic Safety Assessment Regulatory Landscape
Under the current regulatory framework, cosmetics registrants and notifiers can continue to submit a simplified version of the safety assessment report during the registration or notification process until May 1, 2025. Following this deadline, a full version of the safety assessment will be mandated. To facilitate a smooth transition, China is planning to release a set of technical guidelines.
China’s Safety and Technical Standards for Cosmetics (STSC) and Its Updates
The current cosmetic technical standard STSC 2015 specifies the cosmetics' general safety standards, prohibited/restricted/permitted ingredients and testing methods. It is revised aperiodically in response to changing trade practices in the industry. China is planning to issue a new version of STSC.
Cannabis Cosmetics Regulatory Updates in the Asia Pacific Region
Cannabis cosmetics are undoubtedly one of the hottest products across the globe in recent years, but with few regulations. To assist cosmetics companies to avoid compliance risks and seize market opportunity, ChemLinked has compiled the regulations.
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