The article discusses the initiative taken by federal government to establish Drug Regulatory Authority of Pakistan (DRAP) which manage and regulate pharmaceutical trade and industry in Pakistan. Topics discussed include the affect of increasing fees and charges by DRAP on drugs exports, eligibility ...
DRAP是指巴基斯坦的药品监管局(Drug Regulatory Authority of Pakistan)。在巴基斯坦,医疗器械需要经过DRAP的认证才能合法销售和使用。所有医疗设备均受巴基斯坦药品监督管理局(DRAP)医疗设备和药用化妆品部门监管。 分类 上市前审批流程 1、 合格评定程序: 准备合格声明(DoC) 并建立质量管理体系 (QMS),包括符合ISO 13485...
12月12日,浙江博锐生物制药有限公司(以下简称“博锐生物”)宣布,全资子公司海正生物制药有限公司自主研发的阿达木单抗注射液,由巴基斯坦合作方Searle完成当地的注册,成功获得巴基斯坦药品监督管理局(Drug Regulatory Authority of Pakistan,DRAP)批准上市,这是巴基斯坦药品监督管理局批准的首个阿达木单抗产品。 根据博锐生物...
Drug regulation has been identified as a crucial impediment to the progress of Pakistan's health sector, particularly in the wake of the 'Fake Drug Crisis' of 2012. In 2010, control of the Drug Regulatory Authority of Pakistan (DRA), shifted from the federal government to provincial governments...
The difference primarily comes from the stringent Regulatory Compliance norms to be adhered to in Pharmaceutical Operations. In the Pharmaceutical Manufacturing the eMES is also referred as eBMR or “e Batch Manufacturing Record”. The key objectives of implementing “e Manufacturing Execution Systems”...
Inducible cephalosporinase production in clinical isolates of Enterobacter cloacae is controlled by a regulatory gene that has been deleted from Escherichi... Cephalosporin hyper-resistant Enterobacter cloacae strains are isolated with increasing frequency from hospital infections. Resistance is principally due...
Regulatory framework in Pakistan: situation analysis of medicine quality and future recommendations Quality issues in pharmaceuticals are identified as a huge global and public health problem, especially with reference to low- and middle-income countries ... H Rasheed,L Hoellein,KS Bukhari,... - 《...
A. (1995). Elevated DNA repair capacity is associated with intrinsic resistance of lung cancer to chemotherapy. Cancer Research, 55, 4760–4764. CAS PubMed Google Scholar Zhang, H., & Mccarty, N. (2017). Tampering with cancer chemoresistance by targeting the TGM2-IL6-autophagy regulatory ...
Acquisition of Cross-Resistance to Bedaquiline and Clofazimine following Treatment for Tuberculosis in Pakistan. Antimicrobial. Agents Chemother. 2019, 63, e00915-19. [Google Scholar] [CrossRef] [PubMed] [Green Version] De Vos, M.; Ley, S.D.; Wiggins, K.B.; Derendinger, B.; Dippenaar,...
Since 2024, the Medicines and Healthcare products Regulatory Agency (UK) has mandated that systemic fluoroquinolones should only be indicated when there are no other therapeutic alternatives [94]. 2.4. Aminoglycosides Aminoglycosides are well-characterised compounds that are effective against Gram-negative...