Center for Cosmetics Regulation and Research

 Refers to activities involved in safety, efficacy, and

quality monitoring of health products. This shall also
include among others adverse events reporting,
product safety update reporting, collection and testing
of health products in the market, inspection of
licensed establishments, monitoring/surveillance of
unlicensed establishments, product recall activities,
regulatory actions for consumer/product complaints,
monitoring of promotions, advertisements and
sponsorship of health products, health product
verification, Product Information File (PIF) audit, and
post-evaluation of notified health products.
 Pursuant to the Republic Act 9711, FDA Act of 2009,
Article ll Sec. 2(m) of its Implementing Rules and
Regulation, FDA shall institute and strengthen and
maintain the post marketing surveillance system in
monitoring health products.
 ASEAN Cosmetic Directive
 Republic Act 7394 “Consumer Act of the Philippines”
 Presidential Decree no. 881 “Empowering the
Secretary of Health to Regulate the Labeling, Sale and
Distribution of Hazardous Substances”
 Republic Act 10620 “An Act Providing For Toy
And Game Safety Labeling, Appropriating Funds
Therefore” and its Implementing Rules and
Regulations
 Administrative Order 311 s. 1977 “Labeling
Requirements of Hazardous Substances”
 Administrative Order 2005-0015 “Adoption of the
Association of Southeast Asian Nation (ASEAN)
Harmonized Cosmetic Regulatory Scheme and
ASEAN Common Technical Documents”
 Administrative Order 2005-0025 “Implementation
of the Association of Southeast Asian Nation
(ASEAN) Harmonized Cosmetic Regulatory
Scheme and ASEAN Common Technical
Documents”
 Administrative Order 2009-0005 “Revised Policies
and Guidelines on the Regulations on the
Issuances of a License to Operate (LTO),
Certificate of Conformity and Clearance” and its
amendments
 Administrative Order 2014-0038 “Rules and
Regulation Governing Household Urban Pesticide
Licensing”
 Administrative Order 2015-0038 “Removing the
Requirements of Licensing as Importers,
Exporters, Manufacturers, Toll Manufacturers,
Wholesalers, Distributors, Retailers, or Re-Packers
of Those Engage in Certain Household/Urban
Hazardous Substances, and from the Requirement
of Prior Registration and/or Notification of Said
Products”
 Administrative Order 2016-0003 “Guidelines on the
Unified Licensing Requirements and Procedure of the
Food and Drug Administration”
 FDA Circular No. 2014-014 “Minimum Number of
Sample Units Required for each Test Analysis”
 FDA Circular No. 2013-022 “Handling of Consumer
Complaints”
 Bureau Circular 8 s. 2001 “Guidelines in the
Implementation of Product Recall”
 QSP 6.1.3-01 on Collection of Samples for Laboratory
Analysis
 QSP 6.1.3-02 on Post Marketing Surveillance of Health
Products and/or Establishments
 Post-Evaluation of Acknowledged Notifications
 Product Verification
 Product Information File (PIF) Audit
 Advertisements and Promotional Articles
Monitoring
 Adverse Event Reporting for Cosmetic Products
 Processing of Feedback and Complaints
 Product Recall
 Acknowledged Notification is an electronically
generated market authorization for cosmetics
reflecting the following: (1) cosmetic notification
number, (2) validity, (3) brand and product name,
(4)variants, if any, (5) name and address of
manufacture, (6) name and address of the local
company who places the product in the market.
 Post Evaluation refers to the process of evaluating the
acknowledged notification and veracity of information
including product formulation in compliance with
ASEAN Cosmetic Directive and/or TCCA standards,
rules and regulations.
 Refers to the evaluation/assessment of
authorization status, compliance with technical
specifications and labeling requirements, and/or
authenticity of health products being authorized
for sale.
 Such health products subject for verification are
collected and submitted to CCRR by the FDA
inspectorate, NGOs, and law enforcement
agencies.
 Random sampling of products existing in the market
 Evaluation are performed which includes the
following:
◦ Verifying the notification/registration status of the product
◦ Verifying the licensing status of the establishment
◦ Checking compliance to labeling requirements
◦ Cross-checking label information with what was stated in the
notification (includes full ingredient listing, product claims,
etc.)
 Imposing appropriate regulatory action for non-
compliant products e.g. Conduct of product recall,
issuance of FDA Health Advisories; and PIF AUDIT
 The ASEAN Cosmetic Directive (ACD) requires
persons or companies placing a product on the
market to keep a product information file “readily
accessible to the regulatory authority of the
Member State concerned at the address specified
on the label in accordance with article 6 of this
Directive”.
 Conduct of PIF evaluation on-site/at the company
placing the product in the market. It involves
checking of administrative and technical
documents to ensure that the product complies
with quality and safety standards.
 This will be incorporated in the audit agenda of
the FDA inspectorate during post licensing
inspections.
 As stated in Sec. 5 (o) of RA 9711 “FDA Act of
2009”, the FDA is mandated to “prescribe
standards, guidelines, and regulations with
respect to information, advertisements and other
marketing instruments and promotion,
sponsorship, and other marketing activities about
the health products as covered in this Act”.
 The FDA regularly conducts monitoring of
advertisements appearing in various mediums
including television, print, radio, billboards,
flyers, social media, etc.
 The information gathered are then evaluated for
compliance with the standards set in the ASEAN
Cosmetic Directive and RA 7394 “Consumer Act
of the Philippines”.
 If the advertisement is non-compliant, appropriate
regulatory action shall be imposed which may
include:
◦ Issuance of Warning Letters
◦ Product Recall
 Pursuant to the ASEAN Cosmetic Directive,
Article 3 (1) and the Discussion Paper on Post
Marketing Surveillance/Product Safety, it is
important to harmonize the mechanism to gather
and, if necessary, take action on important safety
information arising from post-market surveillance
of cosmetic products.
 During ASEAN Cosmetic Committee meetings
which were conducted twice a year, PMAS reports
were presented for information.
 Adverse Event refers to any genuine harmful or
unintended event reasonably attributable to the
normal or foreseeable use of a given cosmetic
product.
 Serious Adverse Event refers to any untoward
medical occurrence that:
◦ Results in death
◦ Is life-threatening
◦ Requires in-patient hospitalization
◦ Results in persistent or significant disability/incapacity
 The company or person responsible for placing
the cosmetic product in the market shall report to
the regulatory authority of the ASEAN Member
State where the adverse event occurred, regardless
of the source of the report (consumer, healthcare
professional, etc).
 All serious adverse events should be reported.
Non-serious adverse events are not required to be
reported.
 Whenever there is reasonable suspicion that the
cosmetic product might be the cause of the
reaction, reporting is necessary for all serious
adverse events. The expression “reasonable
suspicion” is meant to convey in general that there
are evidences to suggest a causal relationship or
an association.
 There are “non-serious” adverse events that occur
at a high incidence (as defined by the ratio of
events to units sold) of a single “severe” reaction
type that may necessitate rapid communication to
the regulatory authority. However, appropriate
medical and scientific judgment should be applied
for each situation of non-serious, single “severe”
adverse reaction that has a high incidence before
reporting to the regulatory authority.
 Fatal or life threatening adverse event qualify for
very rapid reporting to the regulatory authority,
which shall be notified (e.g. by telephone,
facsimile transmission, email or in writing) as
soon as possible but no later than 7 calendar days
after first knowledge, followed by completing the
Adverse Cosmetic Event Report Form within an
additional 8 calendar days and providing any
other information as may be requested by the
regulatory authority.
 All other serious adverse events that are not fatal
or life threatening must be reported as soon as
possible, but no later than 15 calendar days after
first knowledge.
 The need to protect the consumers from violative
health products is a state policy and enshrined in
our laws, specifically RA 3720 “Food, Drug and
Cosmetic Act” as amended by RA 9711 “Food and
Drug Administration Act of 2009” and RA 7394
“The Consumer Act of the Philippines”. The FDA
is mandated to regulate health products and
establishments with the end view of safeguarding
public health.
 Consumer empowerment does not only mean
providing wide choices of consumer products and
services but also the establishment of mechanism
to effectively address concerns and issue arising
from the quality and standards of products and
services
 Complaints may be filed by proceeding to the
concerned FDA Center/Office, through phone,
and/or email. For CCRR, the contact details are the
following:
◦ Phone: (02)857-1984
◦ Email: [email protected] Subject: CCRR-<Nature of Complaint>
 Accomplish Complaint Form
 The complainant shall be interviewed by the FDA
Representative to determine the appropriate action
needed.
 Attach or submit necessary and supporting
documents such as photos, receipts, medical
certificate, etc.
 For products that require laboratory analysis, the
following are the criteria to be met:
◦ Notified/registered cosmetic/HUHS product
◦ Sample not expired
◦ Suspected presence of adulterants and contaminants
◦ Adverse reaction occurred despite use of product as
directed (to be accompanied by medical certificate)
◦ Sufficient sample. Cosmetic sample shall be >3 g
 The complainant shall be advised by the FDA
representative of the action that will be taken
 Action taken to remove a product from the
market. It is an appropriate alternative method for
removing or correcting marketed products,
including their labeling and/or promotional
literature that violate the laws administered by
FDA.
 Post-Evaluation Reports
 Product Verification Reports
 PIF Audit Reports
 Adverse Cosmetic Reaction Reports
 Advertisements and Promotional Articles
Monitoring Reports
 Feedbacks and Complaints
 Immediately notify the Center of the receipt of the
Notice through call or e-mail
 Refer to Bureau Circular 8 s. 2001and/or ACD for
information regarding the Product Recall process
 Pull-out the affected products from the market
 Prepare the necessary documents which includes:
◦ Inventory
◦ Distribution list
◦ Corrective Action
◦ Preventive Action
◦ Other supporting documents such as sample label,
formulation sheet, claims substantiation, safety assessment
reports, etc.
 Set an appointment with the Center to discuss recall
strategies, timelines and disposition, and submit the
following documents through our PAIR unit
 If a meeting is not possible, submit the documents
through our PAIR unit together with a Letter of Intent
 Submit weekly Recall Status Reports during the recall
process
 Submit a Final Recall Status Report, Disposition and
request for close-out/termination of the Product
Recall