PDF(Pubmed)
Abstract：
UNASSIGNED: The World Health Organization (WHO) advocates the use of reliance practices to enable national regulatory authorities (NRAs) to improve patients\' access to medicines. This study considered whether reliance review translates into swifter medicine authorization.
UNASSIGNED: Abridged review outcomes were examined for New Chemical Entity (NCE) and generic applications to the South African Health Products Regulatory Authority (SAHPRA) in Chemistry, Manufacturing and Controls (CMC) and clinical/bioequivalence (BE), as well as overall NCE authorization times.
UNASSIGNED: SAHPRA NCE CMC review time was 91 days (abridged) vs. 179 days (full), applicant response time was 34 vs. 105 days, respectively, and there was a >2-fold time reduction for abridged vs. full CMC review (125 vs. 284 days). There was a 99-day decrease in clinical approval time through an abridged review (230 vs. 329 days) and a decrease in marketing authorization time for NCE abridged assessment (446 vs. 619 days). SAHPRA review time for generic applications was 97 days (abridged) vs. 191 days (full); applicant response time was 26 days (abridged) vs. 81 days (full) and there was a >2-fold time reduction for CMC and BE abridged vs. full review (122 vs. 272 days).
UNASSIGNED: These results clearly support World Health Organization recommendations for the use of reliance-based regulatory review to expedite the worldwide availability of safe, effective and needed medications.
UNASSIGNED: Abridged review outcomes were examined for New Chemical Entity (NCE) and generic applications to the South African Health Products Regulatory Authority (SAHPRA) in Chemistry, Manufacturing and Controls (CMC) and clinical/bioequivalence (BE), as well as overall NCE authorization times.
UNASSIGNED: SAHPRA NCE CMC review time was 91 days (abridged) vs. 179 days (full), applicant response time was 34 vs. 105 days, respectively, and there was a >2-fold time reduction for abridged vs. full CMC review (125 vs. 284 days). There was a 99-day decrease in clinical approval time through an abridged review (230 vs. 329 days) and a decrease in marketing authorization time for NCE abridged assessment (446 vs. 619 days). SAHPRA review time for generic applications was 97 days (abridged) vs. 191 days (full); applicant response time was 26 days (abridged) vs. 81 days (full) and there was a >2-fold time reduction for CMC and BE abridged vs. full review (122 vs. 272 days).
UNASSIGNED: These results clearly support World Health Organization recommendations for the use of reliance-based regulatory review to expedite the worldwide availability of safe, effective and needed medications.
摘要：
世界卫生组织（WHO）提倡使用信赖做法，以使国家监管机构（NRA）能够改善患者获得药物的机会。这项研究考虑了信赖审查是否转化为更快的药物授权。
■对新化学实体（NCE）和南非卫生产品监管局（SAHPRA）在化学领域的通用应用进行了审查。制造和控制（CMC）和临床/生物等效性（BE），以及总体NCE授权时间。
■SAHPRANCECMC审查时间为91天（删节）与179天（满），申请人的响应时间为34vs.105天,分别,和有>2倍的时间减少删节与完整的CMC审查（125与284天）。通过节略审查，临床批准时间减少了99天（230vs.329天)和NCE删节评估的营销授权时间减少(446与619天）。一般应用的SAHPRA审查时间为97天（删节）与191天（满）；申请人响应时间为26天（删节）与81天（满），CMC和BE删节的时间减少>2倍全面审查(122vs.272天）。
■这些结果明确支持世界卫生组织关于使用基于依赖的监管审查以加快全球范围内安全，有效和需要的药物。
■对新化学实体（NCE）和南非卫生产品监管局（SAHPRA）在化学领域的通用应用进行了审查。制造和控制（CMC）和临床/生物等效性（BE），以及总体NCE授权时间。
■SAHPRANCECMC审查时间为91天（删节）与179天（满），申请人的响应时间为34vs.105天,分别,和有>2倍的时间减少删节与完整的CMC审查（125与284天）。通过节略审查，临床批准时间减少了99天（230vs.329天)和NCE删节评估的营销授权时间减少(446与619天）。一般应用的SAHPRA审查时间为97天（删节）与191天（满）；申请人响应时间为26天（删节）与81天（满），CMC和BE删节的时间减少>2倍全面审查(122vs.272天）。
■这些结果明确支持世界卫生组织关于使用基于依赖的监管审查以加快全球范围内安全，有效和需要的药物。
