Republic of the Philippines

Department of Health
Food and Drug Administration

CDRR’S QPIRA Training

Workshop on Drug Registration

Powerpoint by:
Eliza G. Sison
Food-Drug Regulation Officer III

Presented by:
Kyla G. Catolico
Pharmacist II
Center for Drug Regulation and Research
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08 May 2014
 Republic of the Philippines
Department of Health
Food and Drug Administration

PART I

ADMINISTRATIVE AND
PRESCRIBING INFORMATION

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 Coverage
• Application Form
• Letter of Authorization
• Certifications

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 Application Form (1)

• Letter of application
– Bureau Circular No. 01 s. 2002
 Annex A for NCE and Generic
Applications
› Notarized, duly signed and dated by the
responsible person(s)

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 Application Form (2)

 Product information and the required

oaths and declarations shall be reflected
including additional statements as per
Administrative Order No. 2005-0001
and Administrative Order No. 2005-
0016.

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 Application Form (3)
– Administrative Order 2005-0001
A CPR issued may be cancelled and/or
revoked should the Intellectual Property
Office (IPO) or court of law of
competent jurisdiction decide with
finality that the applicant has no
intellectual property right over a
pharmaceutical product.
FDA shall be held free and harmless
against any and all third-party claims
arising from the registration of a
pharmaceutical product. 6
 Application Form (4)
• Administrative Order No. 2005-0016
–The submitted brand name shall be
changed should the proper authority
decide with finality that the applicant has
no right to utilize the said brand name.
–FDA shall be held free and harmless
against any and all third-party claims
arising from the acceptance of the said
product intended for registration with
FDA.
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 Application Form (5)
• Details of the Active Pharmaceutical
Ingredient (API):

–Name of the API manufacturer shall be

consistent with that declared on the API
Report of Analysis, and/or vice-versa.

–Full business name and address of the

API manufacturer and supplier shall be
reflected.
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 Application Form (6)
• Form 8

–Duly accomplished
–Information shall be consistent with that
declared on the Letter of Application and
other documents provided.

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 Letter of authorization (1)
 Letterhead of Applicant Company
 Heading “ Letter of
Authorization”
 Product owner’s name and address
 Applicant’s name and address
 Registration application
 Product Name

 Dosage Form and Strength

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 Letter of authorization (2)
 With the ______________ (name of
regulatory authority) in ________ (state
country) on our behalf. They will be the
marketing authorization holder of the
registration certificate and be responsible for
all matters pertaining to the regulation of this
product.

 Signature: ______________

 Date: ______________ 11
 Letter of authorization (3)
MODEL OF LETTER OF AUTHORISATION
Company’s Letterhead
LETTER OF AUTHORIZATION
We,
______________________________________________________________
Product Owner’s Name and Address
Hereby appoint
__________________________________________________________
Applicant’s Name and Address
To apply for registration of our pharmaceutical product
Product Name ____________________
Dosage Form and Strength ____________________
With the Drug Regulatory Authority in (state country) on our behalf . They
will be the marketing authorization holder of the registration certificate and
be responsible for all matters pertaining to the regulation of this product.
Signature : __________________
Date : 12
 Certifications (1)
SCOPE
• For contract manufacturing:
a. License of pharmaceutical industries
and contract manufacturer
b. Contract manufacturing agreement
c. GMP certificate of contract
manufacturer

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 Certifications (2)

• For manufacturing “under-license”

(country specific ):

a. License of pharmaceutical industries

b. GMP certificate of the manufacturer
c. Copy of ‘’under-license’’ agreement.
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 Certifications (3)

• For locally manufactured products

(excluding the above):

a. License of pharmaceutical industries

b. GMP certificate ( country specific )

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 Certifications (4)
• For imported products:
a. License of pharmaceutical
industries/importer/wholesaler (country
specific)
b. Certificate of Pharmaceutical Product
issued by the competent authority in the
country of origin according to the current
WHO format (Appendix III)
c. Site master file of manufacturer (unless
previously submitted within the last 2
years) (country specific )
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 Certifications (5)
• Specific requirements
• License of pharmaceutical industries/License-
to-Operate (1)
• For a Drug Manufacturer (including Packer and
Repacker)
• Valid or with proof of renewal
• Shall state the capability to produce the specific
product line/class and dosage form
• Shall declare the name of the drug trader with
toll/contract manufacturing arrangement with
the manufacturer (if applicable)
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 Certifications (6)
• License of pharmaceutical
industries/License-to-Operate (2)
• For a Drug Trader
• Valid or with proof of renewal
• Shall declare the name of the toll/contract
manufacturer and information on the
product to be registered (generic name and
dosage form will usually suffice)
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 Certifications (7)
• License of pharmaceutical
industries/License-to-Operate (3)
• For a Drug Distributor/Importer/Wholesaler
• Valid or with proof of renewal
• Shall declare the corresponding source of
the product including the company name
and business address

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 Certifications (8)
• Contract of manufacturing agreement (1)
• a local manufacturer and a trader
• a local manufacturer and its designated
distributor/wholesaler
• a foreign manufacturer and a distributor/
importer
• a foreign product license holder and a
distributor/importer
• a distributor/importer and its designated
distributor/wholesaler
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 Certifications (9)
• Contract of manufacturing agreement (2)
• Valid/Have not yet expired
• Duly signed by the responsible person(s) of
the parties involved
• Includes the list of products covered in the
agreement
• Declares the specific activities that each
party shall undertake

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 Certifications (10)
• Certificate of Pharmaceutical Product (1)
 For imported products
 In original copy and written/translated in
English
 Valid/Have not expired
 An open-ended certificate is deemed
expired one year after its issuance

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 Certifications (11)
• Certificate of Pharmaceutical Product (2)
 Conforms to the format recommended by WHO
(as per certification scheme on the quality of
pharmaceutical products moving in international
commerce)
 Shall include the following information:
 The Philippines as the importing/requesting
country
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 Certifications (12)
• Certificate of Pharmaceutical Product (3)
 Complete quantitative composition of the
product
 Statement that the product is both
registered and freely sold in the country
of origin
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 Certifications (13)
• Certificate of Pharmaceutical Product (4)
 Statement that the production facilities
conform to Good Manufacturing Practice
(GMP)
 the importing/requesting country

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 Certifications (14)
• Certificate of Pharmaceutical Product (5)
 http://www.who.int/medicines/areas/quality_safety/
regulation_legislation/certification/en/
 Guidelines on the implementation of the WHO
certification scheme
 Contact list of competent authorities of
countries participating in the WHO certification
scheme
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 Certifications (15)
• Certificates of Free Sale and GMP (1)
– For countries not participating in the WHO
certification scheme, the following shall be
submitted:
I. Certificate of Free Sale from the country
of origin
 Written/Translated in English, and duly
authenticated by the territorial Philippine
Consulate
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 Certifications (16)
• Certificates of Free Sale and GMP (2)
 Shall contain the generic name or
international non-proprietary name (INN)
of the active ingredient(s), brand name (if
any), dosage strength and form, and the
complete name and address of the
manufacturer and any other entities which
claim responsibility for the product

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 Certifications (17)
• Certificates of Free Sale and GMP (3)
II. Government certificate attesting to
the registration status of the
manufacturer
 Written/Translated in English, and
duly authenticated by the territorial
Philippine Consulate

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 Certifications (18)
• Certificates of Free Sale and GMP (4)
 Shall state the capability to
manufacture the specific product
line/class and dosage form, and that
the production facilities conform to
GMP.

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 Certifications (19)
• Certificates of Free Sale and GMP (5)
 In case the product is registered but not freely
sold in the country of origin, either one of the
following may be submitted:
I. Original copy of CoPP from another
country with a competent DRA, and
where the product is both registered and
freely sold;
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 Certifications (20)
• Certificates of Free Sale and GMP (6)
II. CFS duly authenticated by the
territorial Philippine Consulate from
another country with a competent
DRA and where the product is both
registered and freely sold; or

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 Certifications (21)
• Certificates of Free Sale and GMP (7)
III. [If the product is not registered in
any other country other than the
country of origin] Export Certificate
duly authenticated by the territorial
Philippine Consulate from the
country of origin.
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 Certifications (22)
• Site master file of manufacturer
– Administrative Order no. 2012-0008
 Adoption and Implementation of the
Pharmaceutical Inspection Cooperation
Scheme (PIC/S) Guides for the Good
Manufacturing Practice (GMP) for
Medicinal Products
 http://www.picscheme.org/publication.phpPE 008-
4 Guideline for PharmaceuticalManufacturers on
the preparation of a site master file
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 Republic of the Philippines
Department of Health
Food and Drug Administration

Thank You!

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