Amendment of the Pharmaceuticals, Medical Devices, etc. Act (registration system for pharmaceuticals, etc. manufacturing industry)
In 2019, the "Act for Partial Amendment of the Act on Ensuring the Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc."
(Act No. 63 of 12, hereinafter referred to as the "Revised Act") was enacted and promulgated on December 4, XNUMX.
Some of the main contents of the revised law are of concern to those who are in the business of pharmaceuticals, quasi-drugs, and cosmetics. I would like to take up the points of the revision this time.
Revision points
The content of concern is indicated in 1-XNUMX-(XNUMX) of the revised law. The following is the description in the revised law.
Regarding manufacturing facilities that only perform storage in the manufacturing process of pharmaceuticals, quasi-drugs, and cosmetics
Once a manufacturing facility has been registered by the Minister of Health, Labor and Welfare, it is no longer necessary to obtain a manufacturing license for the manufacturing facility.
(Article 13-2-2)）
As with all legal amendments, this provision was included in a simple manner.
It has really big implications for the industry.
Let's take a look at ``how it will change'' and ``when it will change'' below.
Classification of conventional manufacturers of pharmaceuticals, etc.
First, let's review how the manufacturing industry of pharmaceuticals, quasi-drugs, and cosmetics has traditionally been managed.
Currently, the Act on Ensuring the Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc.
(hereinafter referred to as the "Drugs, Medical Devices, etc. Act"), Article 13, Paragraphs 1 and 2 provide as follows.
Article 13 A person who is not licensed to manufacture pharmaceuticals, quasi-drugs, or cosmetics,
Each person shall not manufacture pharmaceuticals, quasi-drugs, cosmetics, or medical devices as a business.
Paragraph 2 The permission set forth in the preceding paragraph shall be granted by the Minister of Health, Labor and Welfare for each manufacturing site in accordance with the classification specified by Ordinance of the Ministry of Health, Labor and Welfare.
In other words, currently, the manufacturing industry of pharmaceuticals, quasi-drugs, and cosmetics must receive permission from the Minister of Health, Labor and Welfare.
Furthermore, manufacturers of pharmaceuticals, quasi-drugs, and cosmetics are classified as shown in the table below according to the Enforcement Regulations of the Pharmaceutical and Medical Device Act.
Industry | Name* | clause | article |
Medicine | Specified biological medicines | First26Article1Section No.1issue | order number80Article2Section No.3All or part of the manufacturing process of drugs specified in subparagraphs (a), (c), and (d) (biological products, nationally certified drugs, genetically recombinant technology-based drugs, cell culture technology-based drugs, cell tissue drugs, and specified biological products). something that does |
radiopharmaceutical | First26Article1Section No.2issue | Those that perform all or part of the manufacturing process of radiopharmaceuticals (excluding those listed in the previous item) |
sterile medicine | First26Article1Section No.3issue | Those that perform all or part of the manufacturing process of sterile pharmaceuticals (No.5Excluding those listed in item. ) |
General | First26Article1Section No.4issue | 前3Those that perform all or part of the manufacturing process for pharmaceuticals other than those listed in the following item (excluding those listed in the next item) |
Packaging/Display/Storage | First26Article1Section No.5issue | 前2Packaging, labeling orStoragethose who only do |
Quasi-drug | sterile | First26Article2Section No.1issue | Those that perform all or part of the manufacturing process of sterile quasi-drugs (No.3Excluding those listed in item. ) |
General | First26Article2Section No.2issue | Those that perform all or part of the manufacturing process for quasi-drugs other than the quasi-drugs listed in the previous item (excluding those listed in the next item) |
Packaging etc. | First26Article2Section No.3issue | Packaging, labeling, orStoragethose who only do |
Cosmetics | General | First26Article3Section No.1issue | Can perform all or part of the cosmetic manufacturing process |
Packaging/Display/Storage | First26Article3Section No.1issue | Packaging, labeling,Storagecan only do |
*The name follows the description on the website of the Tokyo Metropolitan Health and Safety Research Center (as of May 2020, 05).
From now on…
How will the above management change under the revised law?
For manufacturing facilities that only store pharmaceuticals, quasi-drugs, and cosmetics,
This means that businesses will be able to operate with registration from the Minister of Health, Labor and Welfare instead of a permit.
However, packaging and labeling, that is, assembly and labeling, etc.
Please note that you still need permission to do this.
When is the enforcement date?
Now that we have sorted out how things will change, let's look at when things will change.
The effective date of the revised law is indicated as follows.
This law shall come into effect from the date specified by Cabinet Order within a period not exceeding one year from the date of promulgation.
However, the following matters will come into effect from the dates specified below.
(1) 1-XNUMX (XNUMX), (XNUMX) (XNUMX), (XNUMX) (XNUMX) and (XNUMX), XNUMX-(XNUMX), and XNUMX-(XNUMX) and (XNUMX)
A date specified by Cabinet Order within a period not exceeding two years from the date of promulgation.
(2) 1-1-(7) A date specified by Cabinet Order within a period not exceeding three years from the date of promulgation.
In other words, this is what it means.
Provision | Effective date |
Revised Act (excluding the following) | The date specified by Cabinet Order within a period not exceeding one year from the date of promulgation. |
However,1-1-(2),(4)(1), (5) (1) and (6), 2 (1) and 3 (1) and (3) | A date specified by Cabinet Order within a period not exceeding two years from the date of promulgation. |
1-1-(7) A date specified by Cabinet Order within a period not exceeding three years from the date of promulgation. | A date specified by Cabinet Order within a period not exceeding three years from the date of promulgation.'' |
The revision points we are taking up this time are 1, 1, and 2, so the relevant parts are in red.
As mentioned at the beginning, the promulgation date is December 12, 4, so
Registration is required for manufacturing facilities that only store pharmaceuticals, quasi-drugs, and cosmetics.
This will be after the date specified in the Cabinet Order by December 3, 12.
I’m looking forward to the issuance of the ordinance!
Reference: Supplement about the implementation date of the revised law
In the revised law, "the date specified by Cabinet Order within a period not exceeding one year from the date of promulgation"
Regarding the enforcement date, a Cabinet Order (Cabinet Order No. 39 of XNUMX) has already been issued.
Its enforcement date has been set.
The contents can be summarized as follows. (The text is reproduced below the table)
Provision | Effective date |
Revised Act No.1Article, Article4Article and Article5Article Supplementary Provisions of the Revised Act13Article, Article15Article, Article17Article, Article18Article, Article21Article, Article22Article, Article24Article to Article26up to article, no.29Article, Article32Article and Article38provisions of article | Reiwa2Years4Mon1Day(2020Year) |
revised law | Reiwa2Years9Mon1Day(2020Year) |
Supplementary Provisions of the Revised Act1Article2The provisions listed in the item | Reiwa3Years8Mon1Day(2021Year) |
Supplementary Provisions of the Revised Act1Article3The provisions listed in the item | Reiwa4Years12Mon1Day(2022Year) |
Reference: Reprint of the main text of Cabinet Order No. 39 of XNUMX
Cabinet Order No. 39, March 11, 2020
Cabinet order specifying the enforcement date of the Act that partially amends the Act on Ensuring the Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc.
Based on the provisions of Article 1 of the Supplementary Provisions of the Act on Partial Amendment of the Act on Ensuring the Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc. (Act No. 63 of 2019), the Cabinet has This Cabinet Order is enacted.
The enforcement date of the Act to partially amend the Act on Ensuring the Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc. (hereinafter referred to as the "Revised Act") is September 1, 2020, and the revised The enforcement date of the provisions listed in Article 1, Item 2 of the Supplementary Provisions of the Act shall be August 1, 2021, and the enforcement date of the provisions listed in Article 3, Item 3 of the same Article shall be December 1, 2020. However, the revised provisions of Article 2, Paragraph 15 of the Revised Act Article 1 (Act on Ensuring the Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc. (Act No. 145 of 1960)) ), Article 4 (excluding the revised provisions of Article 9, Paragraph 1, Item 2 of the Stimulants Control Act (Act No. 252 of 1950)), and Article 5 (Narcotics). and the revised provisions of Article 54, Paragraph 5 of the Psychotropic Substances Control Act (Act No. 14 of 1950) (limited to the part where the ``Stimulants Control Act'' is amended to the ``Stimulants Control Act''). ), as well as the provisions of Articles 13 and 15 of the Supplementary Provisions of the Revised Act (Local Autonomy Act (Act No. 67 of 1945), Appended Table 1 Stimulants Control Act (Act No. 1950) Article 17, Article 18, Article 21, Article 22 (Self-Defense Forces Act (Act No. 100 of 1952) No. 65) limited to the revised provisions of Article 115-3, Paragraph 1), Articles 24 to 26, Articles 29, 32, and 3. The effective date of the provisions of Article 18 shall be April 1, 2020.
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