Revised according to 2024.5.24 MOHW FDA No.

1131102726

Notices for the Plant Master File (PMF) Application

(Including Application Form & Check list)
A. Introduction
In consideration of the PIC/S GMP Guide have already been adopted by Taiwan (R.O.C),
and the Taiwan Food & Drug Administration, Ministry of Health and Welfare (hereafter as
TFDA) became the 43rd member of the Pharmaceutical Inspection Co-operation Scheme
(PIC/S) on January 1, 2013, a risk-based approach has been applied to the assess GMP
compliance. A foreign pharmaceutical manufacturer will be classified into those located in
non-PIC/S-member states, those located in PIC/S member states, or those within the scope of
an agreement (MRA or MOU) signed off with Taiwan on the mutual recognition of inspection.
Pharmaceutical manufacturers located in PIC/S member states that may apply for PMF review
are further divided into three categories — non-sterile products, sterile products, and advanced
therapy medicinal products (ATMPs)/biological medicinal substances and products — in
accordance with the categories of the product they apply for: On January 30, 2013, the revised
Information for Preparing the Plant Master File for Foreign Pharmaceutical manufacturers was
announced, and these three categories and three classes of measures were enforced, in order to
integrate international resources and enhance management efficacy. In order to reduce
duplication in the technical data submitted and enhance efficiency, according to TFDA Risk
No. 1051102938 on June 3, 2016, for foreign pharmaceutical manufacturers that have just
received the GMP Approval letter from the Ministry of Health and Welfare, the TFDA agreed
to referencing to the previous submission or approval letter when reviewing new PMF
application. The principles of application were also announced accordingly.
As pharmaceutical technology and equipment continue to upgrade, the PIC/S GMP
standards are updating. It becomes urgent to revise the Notices for the Plant Master File
(PMF) Application for Foreign Pharmaceutical manufacturers to accommodate the updates
of PIC/S GMP standards; hence, the review standard, requirements, document preparation, and
precautions were reorganized, and the original Forms 1 - 4 were changed to Forms A, B, and
C1-5 in order to facilitate the applicants’ preparation and to enhance submission quality and
time efficiency of review.

B. Review Requirements
I. Legal Basis:
 Article 57 of the Pharmaceutical Affairs Act,
 Pharmaceutical Good Manufacturing Practice Regulations,
 Regulations of Medicament Manufacturer Inspection,
 Standards for Medicament Factory Establishments.
 PIC/S: Guide to Good Manufacturing Practice for Medicinal Products including full
texts and annexes
II. Management System:
1. All pharmaceutical manufacturers located in non-PIC/S member states shall undergo
oversea on-site inspections.
2. Pharmaceutical manufacturers within the scope of an agreement (MRA or MOU) signed

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off with Taiwan on the mutual recognition of inspection: The original copy of the GMP
Certificate issued by the hosting competent authority may be enclosed (the GMP
Certificate shall be within its effective period, and the contents shall include the dosage
form and manufacturing processes applied in the application) in order to apply for
simplified review (i.e., Form A, GMP certificate and the latest version of the SMF shall
be enclosed).
3. Pharmaceutical manufacturers located in PIC/S members states, which are further
divided into the following categories in accordance with the content of the application:
(1) Non-sterile products: Simplified review/full review/Quote review may be applied
for. For full review, the validation dossiers may be waived with alternative dossiers.
(2) Sterile products: Simplified review/full review/Quote review may be applied for.
For simplified or full review, the validation dossiers may be waived with alternative
dossiers.
(3) ATMPs/biological medicinal substances and products: Simplified review/full
review/Quote review may be applied for. For simplified or full review, the
validation dossiers may be waived with alternative dossiers.
III. Application Modes:
1. Applicants may submit the following document to apply for simplified review:
(1) A list of all GMP inspections conducted by the hosting competent authority or other
health authorities in the last five years. The list of inspections should at least include
but not limited to the inspection dates, inspection topics and scopes.
(2) The latest GMP on-site inspection report from hosting competent authority and the
GMP certificate (or other GMP approval dossiers which are issued by the hosting
competent authority).
(i) The dosage forms or manufacturing processes in the PMF application shall be
applicable for the inspection scope.
(ii) Full Chinese or English translations of the GMP inspection report, along with
the full original report.
(3) List of major changes to the applied dosage forms/ manufacturing processes
(including premises, facilities, equipment, and manufacturing process) after said
inspection to the date of submission.
2. Applicants may submit the following alternative document to substitute the Validation
and Qualification documents:
(1) Original or hard copy of the Certificate of pharmaceutical products (CPP) from
EMA or A-10 countries (Germany, US, UK, France, Japan, Switzerland, Canada,
Australia, Belgium, and Sweden.): It should be within two years from the issuance
date.
(2) Validation and qualification summary: The original copies with signed with wet
signature or electronically by the responsible person shall be submitted. The
summary shall include information about the overview for validation and
qualification in the manufacturing site [including utility (HVAC, water, and
process-related gases), equipment and facilities, computerized systems, cleaning
validation, etc.].
(3) Letter of explanation shall be original copies signed with wet signature or
electronically. The contents shall include but not be limited to the following: The
manufacturer is aware that Taiwan FDA has the complete rights to conduct on-site

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inspections according to international practice if need.

3. For applicants to apply PMF for Quote review depending, the dossiers required in
different situations are as following:
(1) An original holder of a GMP approval letter who intends to cite a previous
submission (Including approval letters of overseas on-site inspection, PMF
review, or follow-up inspection) when applying for a PMF review for additional
dosage forms/products/ manufacturing processes at the same plant within the
effective period of said approval letter, shall submit the following documents:
(i) Original copies of letter of explanation signed with wet signature or
electronically by responsible person, which shall specify:
a. Agreement to proceed pursuant to the previous submission.
b. Approval number of previous GMP approval letter issued by Taiwan FDA.
c. Brief description of changes related to the Dosage
form/product/manufacturing process applied in the application effected
since the last PMF application.
(ii) Photocopy of the previous GMP approval letter issued by Taiwan FDA
(iii) The latest SMF (electronic file)
(iv) PMF Inspection Forms A, B, C and relevant document.
(v) Taiwan FDA reserves the right to request further submissions in cases where
the documentation is incomplete or when otherwise necessary.
(2) Applicants intending to cite an GMP approval letter hold by others (Including
approval letters of overseas on-site inspection, PMF review, or follow-up
inspection) when applying for a PMF review for same dosage
forms/products/manufacturing processes, shall submit the documentation listed
below within the effective period of the approval letter. An approval letter with the
same expiry date will be issued if said documentation is reviewed and found in
compliance, and the conditions of the citation will be remarked in the approval
letter.
(i) Original copy of the Letter of Explanation signed with wet signature or
electronically by responsible person, which shall specify:
a. Agreement to proceed pursuant to the previous submission.
b. Approval number of previous GMP approval letter issued by Taiwan FDA.
(ii) Authorization letter from the original holder of the GMP approval letter signed
with wet signature or electronically by responsible person, which shall specify
the official document number of the GMP approval letter and the case number
of the previous submission dossiers, and shall bear the company seal and the
responsible person’s seal.
(iii) Photocopy of the previous GMP approval letter issued by Taiwan FDA.
(iv)The latest SMF (electronic file)
(3) Applicants intending to cite an GMP approval letter hold by others (Including
approval letters of overseas on-site inspection, PMF review, or follow-up
inspection) when applying for a PMF review for additional dosage
forms/products/ manufacturing processes at the same plant within the effective

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period of said approval letter, shall submit the following documents:

(i) Original copy of the Letter of Explanation signed with wet signature or
electronically by responsible person, which shall specify:
a. Agreement to proceed pursuant to the previous submission.
b. Approval number of previous GMP approval letter issued by Taiwan FDA.
c. Brief description of changes effected since the last PMF application.
(ii) Authorization letter from the original holder of the GMP approval letter signed
with wet signature or electronically by responsible person, which shall specify
the official document number of the GMP approval letter and the case number
of the previous submission dossiers, and shall bear the company seal and the
responsible person’s seal.
(iii) Photocopy of the previous GMP approval letter issued by Taiwan FDA.
(iv) The latest SMF (electronic file)
(v) PMF Inspection Form A, B, C and relevant document.
(vi)Taiwan FDA has the rights to request more relevant documents if considered
necessary.
4. For applicants to apply PMF for expansion of manufacturing site, the dossiers are
required as following:
(1) PMF Inspection Form A, B, C and relevant document. For Form-C, only the item
which are marked with asterisk are required, and the relevant documents shall be
enclosed.
(2) Photocopy of the previous GMP approval letter of the site intend to apply for
expansion of manufacturing.
(3) Taiwan FDA has the rights to request more relevant documents if
considered necessary.

C. Administrative Requirements that Should Be Followed when

applying for PMF Review of Foreign Pharmaceutical Manufacturers
I、 Legalization requirements: Based on Article 5, Paragraph 2 of the Regulations of
Medicament Manufacturer Inspection, the PMF application dossier for submission shall
meet one of the following requirements:
1. Plant Master File (PMF) and Site Master File (SMF), which are to be certified by the
hosting competent authority or the chamber of commerce in the country of origin or
legalized by the embassy, representative office or agencies authorized by the Ministry
of Foreign Affairs of R.O.C.
2. Original copy of documents from the hosting competent authority or certified
photocopy of the said documents certified by the hosting competent authority or
chamber of commerce in the country of origin proving that the manufacturer is in
compliance with local pharmaceutical GMP standards. (if the two original documents
mentioned above were already submitted to the TFDA through other cases, a photocopy
of the whole document may be enclosed and indication of the case number that the
original copies were submitted.)
3. Original copy of Certificate of Pharmaceutical Product (CPP) from the hosting
competent authority or certified photocopy of the said documents certified by the

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hosting competent authority or chamber of commerce in the country of origin clearly

stating that said manufacturer is in compliance with local pharmaceutical GMP
standards. (if the two original documents mentioned above were already submitted to
the TFDA through other cases, a photocopy of the whole document may be enclosed
and indication of the case number that the original copies were submitted.)
4. If the paper based GMP certification is no longer available in the country of origin, or
the drug product is contracted manufacturing, the statement of license holder of the
imported drug shall be submitted explaining why the GMP certification and CPP is not
available. Therefore, the applicants could submit the original copy or certified
photocopy of the CPP issued by any one of the A-10 countries, EMA, or by the hosting
competent authority in the country where the contractor is located, in accordance with
the letter TFDA Risk No. 1051105400 dated October 17, 2016.
5. If the electronic GMP or CPP (e-GMP or e-CPP) are issued from the authority of country
of origin, the web link is required for authenticity.
6. For applicants applying PMF for Quote review and for expansion of manufacturing site,
legalization of the dossier is not required.
II、 Authorization Letter:
1. The original Letter of Authorization whereby the foreign manufacturer authorizes the
Taiwan agents (pharmaceutical company) to submit PMF applications. The
authorization letter shall be signed with wet signature or electronically by the
responsible person of the foreign manufacturer.
2. When biological medicinal products/biological active substance/blood products
derived from human blood or human plasma are being applied for, the
products/dosage forms and manufacturing process stage involved in the application
shall be indicated in the Authorization Letter.
3. To apply for Quote review, the Authorization Letter from the manufacturer and the
Authorization Letter from the Taiwan agents who holds the previous GMP approval
letter shall be enclosed.
III、 The latest electronic copy of Site Master File (SMF): SMF shall be written in Chinese
or English. The format and contents of the SMF shall complied with “EXPLANATORY
NOTES FOR PHARMACEUTICAL MANUFACTURERS ON THE PREPARATION
OF A SITE MASTER FILE」(PE008-40)” announced by PIC/S; Otherwise, the
applicants shall compile and assemble the SMF dossier accordingly in order to achieve
successful manufacturing site registration.

D. Dossier should be submitted when applying for an appeal:

I、 Supplemental document for the deficiency listed on the rejection letter.

II、 If there is correction/deletions of dosage form or manufacturing process, the updated

Application Form for Plant Master File (PMF) Review for Foreign Pharmaceutical
manufacturers Form A shall be submitted.

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E. Precautions to Documents to be submitted :

I. The electronic dossiers could be delivered via compact disk (CD), cloud drive and email,
etc.
II. The documents shall, in principle, be prepared on A4 (210 mm x 297 mm) paper and shall
be legible and complete. Manufacturing Site Layout and illustrations are preferably in
color. If the paper is larger than A4, please fold it to A4 size.
III. Applicants are suggested to follow the principle of Good submission practice. In
compiling and assembling of submission dossier, applicants need to ensure that every
document has been prepared consistently and placed in the correct location of the dossier.
IV. Documents that are written in language other than English shall be translated into Chinese
or English, and the accuracy of the contents of translated documents shall be confirmed.
V. The documents shall be signed by responsible personnel from quality assurance
department or related department.
VI. Forms A, B, and C of the PMF for Foreign Pharmaceutical manufacturers shall be
completed and signed off by the Taiwan agents or the quality assurance personnel or
relevant responsible person at the manufacturing site, and the page numbers or
appendixes of corresponding documents submitted for review are to be specified in the
form for each review item. The documents asked for in the Checklist are to be enclosed
as well.
VII. The dossier could be submitted via electronic means with an exception of certified
document (ex, SMF, GMP, CPP). However, if the electronic GMP or CPP are issued from
the authority of country of origin and could be authenticated through a web link, the hard
copy document is not required for submission.
VIII. The dossier, for example, the letter of Explanation, validation and qualification summary,
authorization letter, list of major changes to the applied dosage forms/manufacturing
process, Form C1~C5, shall be signed with wet signature or electronically by the
responsible person of manufacturer.
IX. In case a pharmaceutical company makes use of false information of evidentiary
document(s) in applying for PMF, according to Article 214 of Criminal Code of the
Republic of China, criminal responsibility should be involved, the case shall be referred
to the competent judicial authority for investigation.

F. Precautions to PMF Application:

I. For each application, only one manufacturer site at a single address shall be applied for.
II. For each application, up to 3 dosage forms/products/manufacturing processes shall be
applied for. The dosage forms/manufacturing processes shall be filled out based on
Dosage form Classification Principles of Manufacturer’s authorization and GMP
certification announced by MOHW.
III. The applicant must hold business permit license; if necessary, it may be requested that
such business permit license be enclosed.
IV. The applicants shall completely and correctly fill out the following information in Form
A: description of application [orphan drug, non-sterile products, sterile products (aseptic
preparation or terminal sterilization; Large volume parenteral (LVP) or small volume
parenteral (SVP) products) or biological medicinal products] and application mode

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(Simplified review, full review or with alternative dossiers to substitute the documents of
qualification and validation, quote review).
V. Review fees are charged in accordance with Standards of Review Fees for the
Registration of Western Medicines as most recently announced by the MOHW. Once the
case goes through the review process, no review fees shall be refunded.
VI. If the applicants do not submit PMF document in accordance with Notices for the Plant
Master File (PMF) Application, they will be notified through Taiwan FDA official letter
to re-submit the application document.
VII. The PMF application dossier will not be returned to the applicants.

G. Appendix
I. Application Form for Plant Master File (PMF) Review for Foreign Pharmaceutical
manufacturer_Form A
II. Checklist of Preparing submission dossiers of Plant Master File for Foreign
Pharmaceutical manufacturers_Form B
III. Plant Master File (PMF) Checklist for Foreign Pharmaceutical manufacturer _Form C -
1 Documents in Common review
IV. Plant Master File (PMF) Checklist for Foreign Pharmaceutical manufacturer_Form C -2
Sterile medicinal products/ ATMPs/biological active medicinal substances and products
(simplified review)
V. Plant Master File (PMF) Checklist for Foreign Pharmaceutical manufacturer_Form C -3
All products (Full review)
VI. Plant Master File (PMF) Checklist for Foreign Pharmaceutical manufacturer_Form C -4
ATMPs/biological active medicinal substances and products
VII. Plant Master File (PMF) Checklist for Foreign Pharmaceutical manufacturer_Form C -5
Validation and Qualification