Regulatory Updates

Distribution date: 04 October 2023 | Final date for Comment: 03 December 2023

The Ministry of Food and Drug Safety (MFDS) is proposing to amend the “Regulation for Pharmaceutical Approvals, Notifications and Reviews” as follows:A It will be allowed to use food raw materials in enteric nutritional supplements (Article 3 of the Draft)B. Expansion of the scope of minor changes that do not require approval (Article 3-2 of the Draft)C. Clarification of exemption from submission requirement of Certificate of Pharmaceutical Product (CPP), deletion of CPP for Common Technical Documents submission requirements (Articles 4, 6, and Annex 3 of the Draft)D. Clarification of approval review data requirements for synthetic peptide drug products (synthetic peptide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid(rDNA) origin(peptide of rDNA origin) (Articles 7, 27, and Appendix 1 of the Draft) E. Exemption from submission of genotoxicity test data if there is no change in the manufacturing process as a drug product already used in Korea (Article 7 of the Draft)F. Acceptance of non-clinical data which utilized appropriate non-clinical data and alternative method instead of animal test as a result of on-site inspection for OECD member countries (Article 7 of the Draft)G. Expansion of the scope of Science Citation Index (SCI) into Science Citation Index Expanded (SCIE) (Articles 7 and 14 of the Draft)H. Establishment of submission standards details for ‘Overview of Risk Management Plan’ (newly established in Article 7-2 of the Draft and Annex 6-3)I. Expansion of the scope of recognition of multiple specifications for active pharmaceutical ingredients (API) of pharmaceuticals (Article 12 of the Draft)J. Embodying description method of pharmaceuticals (Article 13 of the Draft)K. Application to MedDRA to specify precautionary information (Article 17 of the Draft)L. Update of safety and efficacy review standards for injections, ophthalmic solutions, and otic solutions(Articles 25 and 27 of the Draft)M. If a bioequivalence test is not possible or meaningless, it can be replaced with a scientifically valid test (Article 27 of the Draft)N. Update of standards for conducting bioequivalence tests for oral anticancer drugs, etc. (Article 27 of the Draft)O. Exemption from stability data in case of contract manufacture of entire process using the same manufacturing method (Article 28 of the Draft)P. Clarification of documents to be submitted for preliminary review (Newly established in Article 55 of the Draft and Annex 20)Q. Addition of National Essential Medicine (NEM) to expedited review categories (Article 58 of the Draft)

Products Covered:  Pharmaceuticals

Regulation Type: Regular notification

Distribution date: 04 October 2023

The proposed Amendments of standards and specifications of Formic acid and establishment its standards and specifications notified in G/SPS/N/JPN/1198 (dated 24 April 2023) has been adopted and published on 26 September 2023.

Products Covered: Formic acid as a feed additive

Regulation Type: Addendum to Regular Notification

Distribution date: 02 October 2023 | Final date for Comment: 01 December 2023

Medicinal cannabis products supplied in New Zealand are required to meet the labelling requirements outlined in regulation 19 of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019. The Ministry of Health is proposing a technical amendment to regulation 19 to add a reference to the requirement for medicinal cannabis products to display a controlled drug classification statement on the label to align with the labelling of all other controlled drugs supplied as medicines in New Zealand. This requirement is already in place and enforced under the Misuse of Drugs Regulations 1977. The proposed change is a clarifying amendment and not a substantive change in regulation. The technical amendment will reflect the existing guidance issued in Section 3.2.2. of the ‘Guideline on the regulation of medicinal cannabis in New Zealand: Part 3’ and the ‘Guideline on the Regulation of Therapeutic Products in New Zealand Part 5’ Section 2.2 and Figure A. 

Products Covered: Medicinal cannabis, including products under HS Chapter 12 and 29.

Regulation Type: Regular notification

Distribution date: 29 September 2023 | Final date for Comment: 28 November 2023

This document specifies the technical requirements of purity, impurity content, moisture content and acidity of fire extinguishing agent perfluorhexanone, describes the corresponding sampling, test methods, and specifies the contents of product inspection, labelling, filling, storage and transportation.This document applies to the development, production, testing and application of fire extinguishing agent perfluorohexanon.

Products Covered: Fire extinguishing agent Perfluorohexanone (HS code(s): 291479); (ICS code(s): 13.220.10)

Regulation Type: Regular notification

Distribution date: 28 September 2023

The proposed maximum residue limits (MRLs) for Dipropyl isocinchomeronate notified in G/SPS/N/JPN/1182 (dated 10 March 2023) were adopted and published 26 July 2023.The specified MRLs are available as below:

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Fish and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)Dairy produce, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09)Animal originated products (HS code: 05.04)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06) 

Regulation Type: Addendum to Regular Notification

Distribution date: 28 September 2023

The proposed maximum residue limits (MRLs) for Mafoprazine notified in G/SPS/N/JPN/1185 (dated 10 March 2023) were adopted and published on 26 July 2023.The specified MRLs are available as below:

Products Covered: Meat and edible meat offal (HS codes: 02.03, 02.06 and 02.09)Animal originated products (HS code: 05.04)Animal fats and oils (HS code: 15.01)      

Regulation Type: Addendum to Regular Notification

Distribution date: 28 September 2023

The proposed maximum residue limits (MRLs) for Metobromuron notified in G/SPS/N/JPN/1184 (dated 10 March 2023) were adopted and published 26 July 2023.The specified MRLs are available as below:

Products Covered: Edible vegetables and certain roots and tubers (HS codes: 07.01 and 07.13)Cereals (HS code: 10.01) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS code: 12.01) 

Regulation Type: Addendum to Regular Notification

Distribution date: 28 September 2023

The proposed maximum residue limits (MRLs) for Pyridachlometyl notified in G/SPS/N/JPN/1178 (dated 10 March 2023) were adopted and published on 26 July 2023.The specified MRLs are available as below:

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.07, 07.09 and 07.10)Edible fruit and nuts (HS codes: 08.07, 08.10 and 08.11)Cereals (HS codes: 10.01, 10.02, 10.03, 10.04, 10.07 and 10.08)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01 and 12.12)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Addendum to Regular Notification

Distribution date: 28 September 2023

The proposed maximum residue limits (MRLs) for Diminazene notified in G/SPS/N/JPN/1181 (dated 10 March 2023) were adopted and published on 26 July 2023.The specified MRLs are available as below:

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02 and 02.06)Dairy produce (HS code: 04.01)Animal originated products (HS code: 05.04)Animal fats and oils (HS code: 15.02)

Regulation Type: Addendum to Regular Notification

Distribution date: 28 September 2023

The proposed maximum residue limits (MRLs) for Pyrimethamine notified in G/SPS/N/JPN/1183 (dated 10 March 2023) were adopted and published on 26 July 2023.The specified MRLs are available as below:

Products Covered: Meat and edible meat offal (HS codes: 02.03, 02.06, 02.07 and 02.09)Animal originated products (HS code: 05.04)Animal fats and oils (HS code: 15.01) 

Regulation Type: Addendum to Regular Notification