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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
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
[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
Philippines Amends Requirements for Application of LTO
Dec 18, 2019
Philippines has released a revised draft of Guidelines on the Unified Licensing Requirements and Procedures of the FDA (hereinafter the Guidelines). Compared with the Guidelines, the significant changes in the draft are related to the amendments to the General Guidelines for LTO, and LTO Application and Renewal Process.
Philippines
Pre-market Approval
NEWS
Philippine Classifies Cuticle Tints Containing Benzalkonium Chloride with Antiseptic/Antibacterial/Disinfectant Claims as Household Remedies
Jun 27, 2018
On May 29th, Philippine released a circular determining cuticle tints containing benzalkonium chloride with antiseptic/antibacterial/disinfectant claims (previously considered as cosmetics) as household remedies...
Philippines
Pre-market Approval
Ingredients
NEWS
Philippines FDA Regulates E-Portal Applications Payment Period
Apr 27, 2018
Philippines FDA recently released a Circular regulating that starting from Apr 28 2018, applications of clients filed through FDA E-Portal are processed only after payment of the amount due has been made. All applications shall be paid within thirty calendar days from the filing thereof. Failure to pay the amount within the specified time shall subject the application to automatic cancellation....
Philippines
Pre-market Approval
NEWS
Philippines to Summarily Reject Cosmetic Notification Applications Due to Incomplete Documentation
Nov 28, 2017
The Philippines FDA decided that from Oct 1st 2017, several industries including the cosmetic industry would receive immediate disapproval when applying for notification or license if incomplete documentation is supplied or if the application fails to meet technical requirements. Regardless of whether or not the application was submitted through...
Philippines
Pre-market Approval
NEWS
Philippines Adopts New License to Operate Format
Jun 12, 2016
On June 7 Philippines FDA released and adopted a new format of License to Operate (LTO) for establishments. The new mandatory format requirement is a supplement to the Order No. 2016-003 “Guidelines on the Unified Licensing Requirements and Procedures” (See CL news on May 6 2016).
Philippines
Pre-market Approval
NEWS
Unnotified Chinese-brand Cosmetics Sold Online Sealed by the Philippine FDA
May 18, 2016
Recently, a line of Chinese brand cosmetics sold online are seal by the Philippine FDA for the lack of proper authorization. With unsound regulations and scrutinize, the cosmetic online market may seem a blank area for law implementation. However, online sold cosmetics shall still be aligned to the local regulation. Through its post-marketing surveillance activities, the Philippine FDA found that several online shopping websites are selling or offering for sale a line of unnotified cosmetics of a brand based on the Chinese province of Guangdong. Cosmetics of this brand found in the Philippine market are currently sealed by the FDA Field Regulatory Office (FROO), which is responsible for monitoring the market for the manufacture, importation, exportation, distribution, sale, offer for sale, transportation, promotion and/or advertisement of the abovementioned cosmetic products. Citizens are advised against purchasing and using those cosmetics for safety’s concern. The FDA then a
Philippines
Pre-market Approval
NEWS
Philippines to Adopt A New Application System for LTO
May 06, 2016
On May 2 2016, Philippines Food and Drug Administration announced that it is to adopt a new application process and form for License to Operate (LTO) which is navigable and accessible on FDA Electronic Portal (e-portal). The new application system will be on a pilot run from June 1 to 31 August. Mandatory use of the web-based application form shall be strictly implemented starting September 1 2016 with no exemptions. The current Integrated Application Form will be replaced as of the same implementation date. To access the e-portal applicants are required to apply an authorized user account by submitting an Authorization Letter and sending a request to pair@fda.gov.ph. Applicants who want to try the new application form during the pilot run shall refer to the following schedules:
Philippines
Pre-market Approval
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Monthly Recap: Global Cosmetic Regulatory Updates | February 2024
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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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