医药指导原则_医药研发指导原则_医药行业指导原则_第2页_摩熵医药(原药融云)

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指导原则

数据库目前收载了2万余条指导原则，包括了国内外（中国、美国、欧洲、WHO等）权威部门（政府机关、NMPA、FDA等）的药政法规、技术指导、卫生防疫、大健康战略等多维度的指导信息。内容丰富、详实、准确，是用户及时应对疾病风险，预测行业动态，把握政策走向提供不可或缺的助力。

指导原则

WHO implementation guidance on emergencies capacity-building: approaches for just-in-time learning response to health emergencies

世界卫生组织（WHO）

2024-09-23
Maternal, newborn, child, adolescent health and ageing and quality of care indicator metadata toolkit: indicator validation guide

世界卫生组织（WHO）

2024-09-23
How to conduct a case-control study to assess the potential risk factors related to human illness caused by Middle East respiratory syndrome coronavirus: protocol, tools and implementation guidance

世界卫生组织（WHO）

2024-09-23
How to sample surfaces in health-care settings for Middle East respiratory syndrome coronavirus: protocol, tools and implementation guidance

世界卫生组织（WHO）

2024-09-23
How to conduct a cohort study to assess the potential risk factors of Middle East respiratory syndrome coronavirus infection among health and care workers in a health-care setting: protocol, tools and implementation guidance

世界卫生组织（WHO）

2024-09-23
How to conduct surveillance and investigations of human infection with Middle East respiratory syndrome coronavirus using WHO’s investigations and studies (‎unity studies 2.0)‎ protocols: protocol, tools and implementation guidance

世界卫生组织（WHO）

2024-09-23
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

美国食品药品监督管理局(FDA)

2024-09-23
Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program : Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

美国食品药品监督管理局(FDA)

2024-09-23
The Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

美国食品药品监督管理局(FDA)

2024-09-23
Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff

美国食品药品监督管理局(FDA)

2024-09-20
国家药监局药审中心关于发布《地舒单抗注射液生物类似药（肿瘤适应症）临床试验指导原则（试行）》的通告（2024年第38号）

国家药品审评中心（CDE）

2024-09-19
国家药监局药审中心关于发布《治疗慢性心力衰竭药物临床试验技术指导原则》的通告（2024年第39号）

国家药品审评中心（CDE）

2024-09-19
Orientations mondiales sur le suivi des politiques des mesures de santé publique et des mesures sociales pendant les urgences sanitaires

世界卫生组织（WHO）

2024-09-19
Principes directeurs relatifs à la hiérarchisation des interventions de lutte contre le paludisme pour obtenir un impact maximal dans les contextes nationaux aux ressources limitées

世界卫生组织（WHO）

2024-09-19
WHO recommendation on screening of pregnant women for intrapartum antibiotic prophylaxis for the prevention of early onset group B streptococcus disease in newborns

世界卫生组织（WHO）

2024-09-18
Conducting Clinical Trials With Decentralized Elements

美国食品药品监督管理局(FDA)

2024-09-18
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for Industry

美国食品药品监督管理局(FDA)

2024-09-18
CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies

美国食品药品监督管理局(FDA)

2024-09-17
Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs

美国食品药品监督管理局(FDA)

2024-09-16
Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements

美国食品药品监督管理局(FDA)

2024-09-13
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry

美国食品药品监督管理局(FDA)

2024-09-13
Clinical practice guidelines for influenza

世界卫生组织（WHO）

2024-09-12
Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised)

美国食品药品监督管理局(FDA)

2024-09-12
Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry

美国食品药品监督管理局(FDA)

2024-09-12
ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA: Guidance for Industry

美国食品药品监督管理局(FDA)

2024-09-11
Health practitioner regulation: design, reform and implementation guidance

世界卫生组织（WHO）

2024-09-10
Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug Administration Staff

美国食品药品监督管理局(FDA)

2024-09-10
Governance of the private sector in fragile, conflict-affected and vulnerable settings

世界卫生组织（WHO）

2024-09-09
Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties

美国食品药品监督管理局(FDA)

2024-09-06
Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry

美国食品药品监督管理局(FDA)

2024-09-05
Bioresearch Monitoring Technical Conformance Guide

美国食品药品监督管理局(FDA)

2024-09-03
Using frozen saltwater packs for short-term transport of vaccines at -25°C to -15°C: interim guidance, June 2024

世界卫生组织（WHO）

2024-08-30
Addressing gender inequalities in national action plans on antimicrobial resistance: guidance to complement the people-centred approach

世界卫生组织（WHO）

2024-08-30
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers: Guidance for Industry and Food and Drug Administration Staff

美国食品药品监督管理局(FDA)

2024-08-29
Practical interim guidance to reduce the risk of infection in people exposed to avian influenza viruses

世界卫生组织（WHO）

2024-08-28
WHO consolidated guidelines on tuberculosis: module 1: prevention: tuberculosis preventive treatment

世界卫生组织（WHO）

2024-08-28
CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology

美国食品药品监督管理局(FDA)

2024-08-28
CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: Methodology

美国食品药品监督管理局(FDA)

2024-08-28
Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff

美国食品药品监督管理局(FDA)

2024-08-26
Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration Staff

美国食品药品监督管理局(FDA)

2024-08-23
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff

美国食品药品监督管理局(FDA)

2024-08-23
Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff

美国食品药品监督管理局(FDA)

2024-08-22
E11A EWGPaediatric Extrapolation

人用药品注册技术要求国际协调会(ICH)

2024-08-21
Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA: Guidance for Industry

美国食品药品监督管理局(FDA)

2024-08-20
Acceptable Media for Electronic Product User Manuals: Guidance for Industry and FDA Staff

美国食品药品监督管理局(FDA)

2024-08-19
Guidance on wastewater and solid waste management for manufacturing of antibiotics

世界卫生组织（WHO）

2024-08-16
Global guidance on monitoring public health and social measures policies during health emergencies

世界卫生组织（WHO）

2024-08-16
Planning for health system recovery: guidance for application in countries

世界卫生组织（WHO）

2024-08-15
Draft Guidance for Industry: Voluntary Sodium Reduction Goals (Edition 2)

美国食品药品监督管理局(FDA)

2024-08-15
Diphtheria outbreaks: comprehensive guidance for the public health preparedness and response in the WHO African Region, February 2024

世界卫生组织（WHO）

2024-08-13

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