| 1. | 通報(bào)成員：尼加拉瓜 |
| 2. | 負(fù)責(zé)機(jī)構(gòu)：Ministerio de Salud (Ministry of Health) Dirección General de Regulación Sanitaria, DGRS (Directorate-General of Health Regulation) Direccion de Farmacia (Pharmacy Directorate) |
| 3. |
通報(bào)依據(jù)的條款：Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ]
通報(bào)依據(jù)的條款其他：
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| 4. | 覆蓋的產(chǎn)品：ICS 11.120.01
ICS：[] HS：[] |
| 5. |
通報(bào)標(biāo)題：Nicaraguan Mandatory Technical Standard (NTON) No. 19 013-20: Medicines for human use. Products of biological origin and biosimilars. Registration requirements頁(yè)數(shù)：160 使用語(yǔ)言：西班牙語(yǔ) 鏈接網(wǎng)址： |
| 6. |
內(nèi)容簡(jiǎn)述： The notified Technical Standard establishes the requirements governing the registration of biological products and biosimilars for human use, the renewal of and changes to sanitary registration, and the batch release of such biological products, based on a risk assessment. It applies to natural and legal persons engaged in the manufacture, importation, distribution and marketing of biological products and biosimilars for human use. |
| 7. | 目的和理由：Protection of human life and health |
| 8. | 相關(guān)文件： 1.Resolución Ministerial 212-2016, MINSA Procedimiento para la verificación de la calidad de medicamentos de uso humano en la etapa de post comercialización;2.Resolución Ministerial 213-2016 MINSA Adenda al Procedimiento para la verificación de la calidad de medicamentos de uso humano en la etapa de post comercialización;3.Resolución No. 188-2006 (COMIECO XL) que aprueba el Reglamento Técnico Centroamericano. Productos Farmacéuticos. Validación de métodos analíticos para la evaluación de la calidad de los medicamentos (NTON 19 003 - 06/RTCA 11.03.39:06);4.Resolución No. 214-2007 (COMIECO XLVII) que aprueba el Reglamento Técnico Centroamericano. Verificación de la Calidad de los Medicamentos para Uso Humano (NTON 19 006 - 06/RTCA 11.03.47:07);5.Resolución No. 148-2005 (COMIECO XXXIII) que aprueba el Reglamento Técnico Centroamericano. Primera actualización Productos Farmacéuticos. Estudios de Estabilidad de Medicamentos para uso humano (NTON 19 002 - 10/ RTCA 11.01.04:10);6.Resolución No. 340-2014 (COMIECO LXVII) que aprueba el Reglamento Técnico Centroamericano. Etiquetado de Productos Farmacéuticos para Uso Humano. (NTON 19 001 - 05/RTCA 11.01.02:04);7.International Conference on Harmonization (ICH) Guidelines on Stability Testing. Guideline Q5C, Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products;8.ICH Guideline S6, Biotechnological Products. Preclinical Safety Evaluation of Biotechnological-Derived Pharmaceuticals;9.WHO Requirements for the collection, processing and quality control of blood, blood components and plasma derivatives. WHO Technical Report Series No. 840, Annex 2 (adopted by the WHO Expert Committee on Biological Standardization in 1992);10.ICH Guidelines on Stability Testing. Guideline Q5C, Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products;11.Guidelines on evaluation of similar Biotherapeutic Products (SBPs), Annex 2, Technical Report Series No. 977, 2013;12.Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs), Annex 2, Technical Report Series No. 1004, 2016;13.ICH Guideline S6, Biotechnological Products. Preclinical Safety Evaluation of Biotechnological-Derived Pharmaceuticals;14.ICH Guideline M3 (R2), Guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals;15.WHO Good Clinical Practices: Document of the Americas;16.ICH Quality Guidelines (Q1, Q2, Q3, Q4, Q5 and Q6) and ICH Guideline M10: Bioanalytical Method Validation;17."Manual para el Procedimiento de Registro de Productos Biológicos y Biosimilares de Uso Humano";WHO guidelines for good clinical practice (GCP). |
| 9. |
擬批準(zhǔn)日期：
To be determined 擬生效日期： To be determined |
| 10. | 意見(jiàn)反饋截至日期：60 days from notification |
| 11. |
文本可從以下機(jī)構(gòu)得到：
Ministerio de Fomento, Industria y Comercio (Ministry of Development, Industry and Trade) Km 6 Carretera a Masaya Managua, Nicaragua Tel.: (+505) 2248 9300, Ext. 1314 or 1310 Email: notificacion@mific.gob.ni; normalizacion@mific.gob.ni; imartinez@mific.gob.ni |
The notified Technical Standard establishes the requirements governing the registration of biological products and biosimilars for human use, the renewal of and changes to sanitary registration, and the batch release of such biological products, based on a risk assessment.
It applies to natural and legal persons engaged in the manufacture, importation, distribution and marketing of biological products and biosimilars for human use.
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