(1) Reasons for Proposal
The amendment aims to extend the range of drug products that may be manufactured on consignment and enable rare drug products to separately obtain a permit, thereby improving the current system.

(2) Major Provisions
A. Under the current system, a product with the same content of active ingredient in a unit dosage form and with the same route of dosage form administration is to be permitted as one item. However, henceforward, an orphan drug may be permitted as a separate item (Article 3, paragraph 1).
B. A domestic pharmaceutical company may manufacture drug products by entrusting part of the manufacturing process to an overseas manufacturing establishment it founded or in which it holds equity, and drug product importers may entrust part of the manufacturing process for imported items to domestic manufacturers (Article 3, paragraph 10 and Article 21, paragraph 5).
C. If changing the matters in a package unit by including them in a category of minor matters, the details of change shall be notified through electronic recording media (Article 3-2, paragraph 2, subparagraph 6 newly inserted)
D. If changing the strain of the permitted influenza vaccine, the product safety and efficacy shall be secured through examination (Article 5)
E. In the case of drug substance, the method of describing its efficacy and effect, usage and dose, and directions for use shall be clearly defined (Article 15, Article 16, subparagraph 5, Article 17).
F. Usage and dose for infants, children, pregnant women, and older people shall be separately described (Article 16, subparagraph 6)
G. Since drug products permitted to be as a ‘Company’s or Manufacturer’s Package Unit’ does not indicate its package unit, with the result that consumers cannot understand how a particular product is distributed in terms of dose and quantity, information about a package unit for drug products shall be provided (Article 18, paragraph 2).
H. Where there is consent of an applicant to orphan drug status, a basis is provided for designating it to be reexamined (Article 22, paragraph 3.)
I. Requirements for submission of clinical trial data about blood derivatives shall be relaxed so that a clinical trial sourcebook may be replaced by the data on the status of current domestic use (Attached Table 1)
J. In a case where clinical trials for efficacy cannot be conducted or where there are vaccines requiring long-term assessment of immunogenicity, long-term safety and efficacy verifications shall be obtained after risk management plans are permitted (Attached Table 9-2).
(3) Amendment Details
Proposed Notification of a Partial Amendment to Regulations Concerning Permission for and Examination of Items such as Biological Products

Part of the regulations concerning permission for and examination of items such as biological products shall be amended as follows.
In Article 2, subparagraph 23, ‘the thing in the state’ shall be amended to read ‘the drug substance in the state,’ and in the same Article, ‘the thing in the state’ shall be amended to read ‘the drug substance in the state.’
In Article 3, paragraph 6, “in case” shall be amended to read “in case or in the case of the item deemed to be reasonable to manufacture it by mixing it (ex. a serial product requiring consecutive administration of two products in terms of usage and dose),” and in the same Article, paragraph 7, the “prefilled syringe” shall be amended to read the “prefilled syringe, cartridge, pen,” Paragraph 1 and paragraph 10 shall be as follows:
  ① When falling under any of the following subparagraphs, an identical manufacturer, manufacturer and seller on consignment, and importer shall be permitted (including permission for change. Hereinafter referred to as ‘permission for items’) to manufacture and sell (import) the following product as one item.
  1. In the case of a drug substance, if the item’s ingredient name and specifications (standards) are the same
  2. In the case of the item other than subparagraph 1, the item whose content of active ingredient per unit dosage form (in the case of a liquid product, its content and concentration) and whose route of dosage and form of administration are the same. Provided that the following items are excepted.
   a. Where the special characteristics of a product are recognized within the scope of the same specifications,  
   b. Where the need for separate permission is recognized for public health because the item is a separate item which uses a new strain or its manufacturing method is distinctly different,
   c. Where the drug product is intended only for export,
   d. Orphan drug
  ⑩ In the case of a drug product falling under any of the following subparagraphs, permission may be sought by entrusting its manufacturing to a drug product manufacturer located in a foreign country, in accordance with Article 31, paragraph 2 and paragraph 11, and Article 12 of the「Rules on the Safety of Drug Products, etc.」.   
   1. As a drug product manufactured by using a new biotechnology, if there are not facilities for entrusted manufacturing due to its special characteristics or if manufacturing on consignment is recognized as being impossible
   2. Where a domestic pharmaceutical company entrusts part of the manufacturing process to a drug product manufacturer established in a foreign country to manufacture specific drug products,
In Article 3-2, paragraph 2, subparagraph 1,  “「The Korean Pharmacopeia」, 「Standards for Drug Products Outside of the Korean Pharmacopeia」” shall be amended to read “「The Korean Pharmacopeia」”, and subparagraphs 6 and 7 of the same paragraph shall be changed to subparagraphs 7 and 8, respectively, and subparagraph 6 of the same paragraph shall be newly inserted as follows: 
   6. Changing the package unit. However, changes in dose or mass per unit container shall be excepted. 
Article 5, paragraph 1, subparagraphs 1 and 2 shall be deleted, with the following proviso.
  Provided that where biological products whose types of effective ingredient, specifications, content (concentration in the case of liquid product), and dosage form are identical to the item currently permitted, and whose final stock solution and the manufacturing establishment for finished products are the same shall be exempted from screening.
In the part outside of Article 5, paragraph 2, and its each subparagraph, “notwithstanding paragraph 1, subparagraph 1” shall be amended to read “among the permitted drug products,’ and in the proviso to Number 4 of the same Article, “drug products, etc.” shall be amended to read “drug products,” “「Safety Information Management Regulations Including Drug Products, etc.」(Public Notification by the Ministry of Food and Drug Safety)” shall be amended to read  “「Rules on the Safety of Drug Products, etc.」[Attached Table 4-3].”
The proviso to Article 10, paragraph 3 shall be as follows:
  Provided that where a dosage form is newly recognized or its special characteristics are recognized pharmaceutically, or it is necessary to be separately managed (ex. prefilled syringe injection, pen injection, cartridge injection, etc.), the fact may be described.
The title of Article 15 “Efficacy and Effect” shall be amended to read “Efficacy• Effect,” and in the part outside of each subparagraph, “any one of each subparagraph” shall be amended to read “each subparagraph.” Subparagraph 5 shall be newly inserted.
   5. In a case where a drug substance which is rarely used separately or whose individual efficacy and effect are difficult to recognize, it may be described as “for manufacture.”
In the part outside of each subparagraph of Article 16,  “any one of each subparagraph” shall be amended to read “each subparagraph.” Subparagraphs 5 and 6 shall be newly inserted as follows:
   5. In a case where a drug substance which is rarely used separately or whose individual usage and dose are difficult to determine, it may be described as “shall be appropriately used when manufacturing finished drug products.” 
   6. Usage and dose for infants, children, pregnant women, and older people may be separately described.
Article 17, paragraph 2 shall be as follows:
  ② In the case of a drug substance, it shall be described in order of the following subparagraphs, and where necessary, other matters may be described.
   1. It shall be used for manufacturing drug products.
   2. If a single product has once been used, instructions for using single products.
   3. Instructions for storage and handling.
Article 18, paragraph 2 shall be as follows:
  ② When falling under any of the following subparagraphs, each specified package unit shall be described, except that if there are special characteristics in terms of dosage form or usage/dose or its validity is recognized considering its intended purpose, an exception may be made for it. 
   1. Injections shall be described in terms of dose or mass (or content of active ingredient) of vials, ampules, or prefilled syringe, etc., manufactured (imported).
   2. The dosage form outside of subparagraph 1 shall be the dose, mass (or content of active ingredient) equivalent to dosage.
   3. In a case where a drug substance is manufactured, it shall be described in “Company’s Package Unit, whereas in a case of importing it, it shall be written in “Manufacturer’s Package Unit.”
In Article 21, paragraph 4, the “manufacturer and manufacturing establishment described in the certificate of manufacture” shall be amended to read the “name and location of the manufacturing establishment,” and paragraph 5 of the same Article shall be newly inserted as follows:
  ⑤ Where part of the manufacturing process for an imported product (excepting the packaging process for finished products) is entrusted to a domestic manufacturer, the domestic manufacturer may be added as an entrusted manufacturer.  
In Article 22, paragraph 1, the “safety and efficacy, their standards and test methods” shall be amended to read the “safety and efficacy, their standards and test methods, the status of implementation of the standards for drug product manufacturing and quality control (for military or government use only) pursuant to Article 4, paragraph 1, subparagraph 6 of the Rules on the Safety of Drug Products, etc.”; paragraph 3 of the same Article shall be amended to read paragraph 4; the “orphan drug” in paragraph 4 (previously paragraph 3) shall be amended to read the “orphan drug” in paragraph 3). Paragraph 3 of the same Article shall be newly inserted as follows:.
   ③ Orphan drugs shall be designated to be reexamined (only in cases where an applicant consents to it) pursuant to Article 22 (1) 2 (b) of the Rules on the Safety of Drug Products, etc.
In Article 28, subparagraph 3,  “blood derivatives” shall be amended to read “blood derivatives or plasma derivatives (hereinafter “blood derivatives, etc.”), and in the part outside of the same subparagraph, three subparagraphs of item (c), the “blood derivatives” shall be amended to read “blood derivatives, etc.”; in (c) (i) a of the same subparagraph, the “collected blood (blood components)” shall be amended to read the “collected blood,” and “blood derivatives” shall be amended to read “of blood derivatives, etc.” In the same item (i) b and (i) b 1, “blood (blood components)” shall be amended to read “blood.”
In Article 30, subparagraph 3, (d), (i), “source and lot number” shall be amended to read “origin and supply source.”
In Article 31, subparagraph 2, (a), (ⅱ), “data spectroscopic” shall be amended to read “spectroscopic,” and in the same Article 31, subparagraph 3, (a), (ⅱ), b, “media component-related data, the data that can prove safety including source and lot number” shall be amended to read “the data relating to media manufacturing methods, media composition, and their special characteristics including storage method after manufacturing,” and in the same Article 31, subparagraph 3, (c), a, “source and lot number” shall be amended to read “origin and supply source.”
The Attached Table 1 shall be amended as in Exhibit.
The Attached Table 9-2, subparagraph 3, (b), (ⅲ) shall be newly inserted as follows:
   3) With respect to vaccines on which clinical trials for efficacy cannot be conducted or which require long-term immunogenicity, plans for evaluating their effectiveness or conducting long-term immunogenicity tests shall be submitted, together with the reports on their results.

Addenda

Article 1 (Enforcement Date) This notification shall enter into force from the date it is notified.
Article 2 (Examples of Application) The amended provisions including Article 3, Article 3-2, paragraph 2, Article 15, Article 16, Article 17, paragraph 2, Article 18, paragraph 2, Article 21, paragraph 5, Article 22, Article 28, Article 30, attached Table 1 and attached Table 9-2 shall apply to the drug product applying for permission (including permission for change) for manufacturing and importing items following the enforcement of this notification.
Article 3 (Transitional Measures for Permitting Items) This notification shall follow the previous provisions in cases where applications were made for permission for manufacturing, selling (importing) items (including permission for change) in accordance with the previous provisions, notwithstanding the amended provisions as stipulated in Article 3, Article 3-2, paragraph 2, Article 15, Article 16, Article 17, paragraph 2, Article 18, paragraph 2, and Article 21, paragraph 5.
Article 4 (Transitional Measures for Changes in Package Unit) A person who obtained permission for manufacturing and importing items of drug product in “Company’s Package Unit” or “Manufacturer’s Package Unit” according to the previous provisions prior to the enforcement of this notification may manufacture or import the relevant items pursuant to the previous provisions for 1 year after the enforcement date of this notification notwithstanding the amended provision of Article 18.