Regulations of the lot release procedures for biologics

Regulations of the Lot Release Procedures for Biologics (Amended Date 2014.10.23) Article 1 Article 2

Article 3

These regulations are enacted pursuant to Paragraph 1, Article 74 of the Pharmaceutical Affairs Act. These Regulations are applicable to serum, antitoxins, vaccines, toxoids and bacterial suspensions produced by microbiological and immunological methods.

After biologics being imported or manufactured, pharmaceutical firms shall fill out an application form for lot release procedures of Biologics (as per attachment 1), and submit the application along with the following to the central competent health authority, and pay the assessment fee upon notice (including testing fee, lot release fee, travel and delivery fee): 1. Importing packing list 2. Drug approval license or a copy of the approval document from the central competent health authority 3. Lot release certificate issued by the health authority of country of origin may be replaced by reviewing summary protocol and certificate of analysis from the manufacturer where the original health authority allows self-release 4. Literatures regarding the manufacturing process, testing method, specifications, and standards of the biologics 5. Standard operating procedures (SOP) of source management on animal raw materials and proof of source of raw material 6. Summary protocol of biologics during manufacturing process, and testing records and the certificate of analysis of finished products Domestic manufacturer shall apply for lot release referred in the preceding Paragraph after the product being tested by the manufacturer and complied with the specification, and is exempt from providing information in the preceding first and third Subparagraph.

Biologics for epidemic controlor exportation use, submission of documents mentioned in Paragraph1, Subparagraph 6can be postponed until the date before the release of the product upon permission of the central competent authority.

Pharmaceutical firms failure to pay the assessment fee, fill out the application, submit all necessary document or comply with

Article 4

Article 5

Article 6

Paragraph 1 shall complete all process upon notice of the central competent health authority within two months.

Pharmaceutical firms failure to complete the process within the deadline, shall file an extension with written reasons before the deadline; the period of extension, if permitted, is one month after the date of the deadline, and such extension will be granted only once.

Pharmaceutical firms failure to complete the process before the deadline, or before the expiration of the one-month extension period, the central competent health authority may perform review on the basis of existing information and accept or reject the application.

Attachment 1ďźšApplication form for Lot Release Procedures of Biologics.DOC Upon receiving application for lot release, the central competent health authority shall dispatch an agent to check if temperature for transportation and storage of biologics complies with requirements, and shall sample appropriate amount of biologics for inspecting and sampling; The remainder of biologics shall be sealed and kept by the pharmaceutical firms.

The central competent health authority shall conduct reviewing and testing according to the type of sampled biologics, when necessary.

Released biologics may be sold and supplied after receiving a Drug Approval Seal from the central competent health authority and attached to each container.

The Certificate of Lot Release of Biologics (as per attachment 2) or the Lot Release Certificate (as per attachment 3) shall be issued by the central competent health authority to those pharmaceutical firms who apply for lot release.

Attachment 3ďźšLot Release Certificate.DOC Attachment 2ďźšLot Release Certificate (Please Refer to Attachment 3 for the English vision).doc In accordance with national epidemic control policy or in case of serious emergencies, or special medical purpose, biologics with approval of the central competent health authority, may be exempted from testing in the Article 5.

The biologics in the preceding Paragraph may be sold and supplied after documents and temperature of transportation and storage of biologics comply with requirements, and the Drug Approval Seal has been attached with each container. The Certificate of Lot

Article 7

Article 8

Article 9

Release of Biologics or the Lot Release Certificate shall be issued by the central competent health authority to those pharmaceutical firms who apply for lot release.

In the circumstances described in the preceding Paragraph, the central competent health authority may, when necessary, take samples of biologics to test for compliance with requirements.

Biologics for emergency medical use, pharmaceutical firms may submit an undertaking statement from an attending physician in a district or higher level hospital or submit an application from the hospital, to apply for necessary amounts for emergency release.

The biologics in the preceding paragraph, after the central competent health authority review the certificate of analysis from the original manufacturer, can be released with the emergency release seal attached to each container of the biologics in the applied amount.

The undertaking statement or application in the first paragraph shall list the name of the drugs that patients need, the reason of usage and the amount.

Pharmaceutical firms shall keep the information associated with the lot number of the biologics for emergency use, the users and the amount, for future reference.

The central competent authority may authorize its subordinate organization, the Food and Drug Administration, to manage the relevant matters of lot release procedures for biologics referred in Articles 3 to 7 of these Regulations.

These Regulations shall come into force on the date of promulgation.

Attachment 1: Application form for Lot Release Procedures of Biologics Applicant

（stamp）

Firm name Address

（sign and stamp）

Representative Telephone Apply for biologics

Certificate of Lot Release of Biologics(Copies)： Lot Release Certificate (for exportation)(Copies)：

Drug that apply

Product name (Chinese)

for inspecting

Drug Permission number

and

Product name (English)

Lot number

batch-sealing

Ingredients and Strength

Expiry Date

Type of container

Storage temperature

Original

Company

Importation Date

Manufacturer

name

Year

Month

Date

Address Import

Amount

Manufacture

Batch-sealing /

Amount

Export Drug Approval Seal

Required documentation

(1)Importing Packing list (Not apply to domestic products).

(2)Lot Release certificate issued by the health authority of country of origin.(Not apply to domestic products).

(3)Drug approval license or a copy of the approval document from the central competent health authority.

(4)Documents of the manufacturing processes, testing methods, specifications, and standards of the biologics and related literatures. □：If the documents from the original manufacturer are identical to those being recognized during previous process of applying for drug approval license, item(4) can be waived.

(5)Standard operating procedures (SOP) of source management on animal–derived materials and proof of source of derived materials. □：If the documents from the original manufacturer are identical to previous application, item(5) can be waived.

(6)Summary protocol of biologics during manufacture processes, and testing records and the certificate of analysis of finished products. □：If the biologics are used for prevention of epidemic disease or exportation, the submission of item(6) can be postponed until the date before the release (permission from the central competent authority is required).

附件二、生物藥品封緘證明書 ( Lot Release Certificate )( Please Refer to Attachment 3 for the English vision)

衛生福利部食品藥物管理署 生物藥品封緘證明書 FDA 研字第 OOOOOOOOOO 號

申請廠商: 製劑名稱: 製造廠名: 批號:

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有效日期: 包裝: 封緘數量: 封緘劑量:

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上述生物藥品之封緘檢驗案，符合生物藥品檢驗封緘作業之規定，予以封緘，此證。

署長

○○○

中華民國

年

月

日

附件三、外銷用生物藥品批次放行證明書 ( Lot Release Certificate )

衛生福利部食品藥物管理署 Food and Drug Administration, Ministry of Health and Welfare 地址：11561 臺北市南港區昆陽街 161-2 號

161-2, Kunyang St. Nangang, TAIPEI, 11561, TAIWAN (R.O.C.)

TEL：(02)2787-8000 http://www.fda.gov.tw

LOT RELEASE CERTIFICATE No. TFDA-RA-XXXXXXXXXX MMM. DD, YYYY The lot referenced below meets the national requirements for lot release and conforms to the approved specifications. The lot has been tested on the basis of critical evaluation of the manufacture’s production and control protocols and on the basis of the evaluation of samples at the Food and Drug Administration.

Product trade name Common name Lot number Expiry date Number of containers Number of doses per container Type of container Dosage form Strength of the product Name and address of manufacturer Signed by Director, Division of Research and Analysis Under the delegated authority of Director-General Food and Drug Administration Ministry of Health and Welfare Executive Yuan, Republic of China