| 1. | 通報(bào)成員：韓國(guó) |
| 2. | 負(fù)責(zé)機(jī)構(gòu)：Ministry of Food and Drug Safety |
| 3. |
通報(bào)依據(jù)的條款：Technical Regulation (Article 2.9.2)
通報(bào)依據(jù)的條款其他：
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| 4. | 覆蓋的產(chǎn)品：Pharmaceuticals
ICS：[] HS：[] |
| 5. |
通報(bào)標(biāo)題：A partial amendment to Regulation for Pharmaceutical Approvals, Notifications and Reviews頁(yè)數(shù)：15?page(s) 使用語(yǔ)言：in Korean 鏈接網(wǎng)址： |
| 6. |
內(nèi)容簡(jiǎn)述： The Ministry of Food and Drug Safety (MFDS-) of the Republic of Korea is issuing the proposed amendments to the MFDS Notice "Regulation for Pharmaceutical Approvals, Notifications and Reviews" as follows: - The scope of pharmaceuticals that are required to submit Common Technical Document (CTD) for review under Article 6 would be expanded to include preparations for which specialty dosage forms are authorized (such as extended release products) and the drugs requiring safety and efficacy assessment such as injections, ophthalmic solutions and otic solutions whose excipients are different from those of the previously approved drug. - When drugs are outsourced for manufacturing in the manufacturing sites drugs manufactured from which have gone through bio equivalence (BE) test, they are newly required under Article 28 to submit BE test data for review.
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| 7. | 目的和理由：To harmonize global regulation of generic medicines |
| 8. | 相關(guān)文件： MFDS NOTIFICATION No. 2019-192 (15 April 2019) |
| 9. |
擬批準(zhǔn)日期：
To be determined 擬生效日期： To be determined |
| 10. | 意見反饋截至日期：60 days from notification |
| 11. |
文本可從以下機(jī)構(gòu)得到：
Technical Barriers to Trade (TBT) Division Korean Agency for Technology and Standards (KATS) 93, Isu-ro, Maengdong-myeon, Eumseong-gun, Chungcheongbuk-do, 27737 Republic of Korea Tel.: (+82) 43 870 5525 Fax: (+82) 43 870 5682 E-mail: tbt@kats.go.kr website: http://www.knowtbt.kr
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The Ministry of Food and Drug Safety (MFDS-) of the Republic of Korea is issuing the proposed amendments to the MFDS Notice "Regulation for Pharmaceutical Approvals, Notifications and Reviews" as follows:
- The scope of pharmaceuticals that are required to submit Common Technical Document (CTD) for review under Article 6 would be expanded to include preparations for which specialty dosage forms are authorized (such as extended release products) and the drugs requiring safety and efficacy assessment such as injections, ophthalmic solutions and otic solutions whose excipients are different from those of the previously approved drug.
- When drugs are outsourced for manufacturing in the manufacturing sites drugs manufactured from which have gone through bio equivalence (BE) test, they are newly required under Article 28 to submit BE test data for review.
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