scholarly journals Paediatric Pharmacotherapy and Drug Regulation – Moving Past the Therapeutic Orphan

2021 ◽  
Author(s):  
Charlotte Moore‐Hepburn ◽  
Michael Rieder
Keyword(s):  
Drug Regulation

scholarly journals Transparency in drug regulation: public assessment reports in Europe and Australia

2016 ◽  
Vol 21 (11) ◽  
pp. 1806-1813 ◽  
Author(s):  
Peter Papathanasiou ◽  
Laurent Brassart ◽  
Paul Blake ◽  
Anna Hart ◽  
Lel Whitbread ◽  
...  
Keyword(s):  
Drug Regulation ◽  
Assessment Reports

Malaria Drug Regulation

Science ◽  
2002 ◽  
Vol 296 (5567) ◽  
pp. 425m-425
Keyword(s):  
Drug Regulation

scholarly journals FDA tightens its grip on drug regulation

BMJ ◽  
2007 ◽  
Vol 334 (7588) ◽  
pp. 290-291 ◽  
Author(s):  
Rebecca Coombes
Keyword(s):  
Drug Regulation

WHEN DRUG REGULATION FAILS

The Lancet ◽  
1984 ◽  
Vol 323 (8379) ◽  
pp. 718-719
Keyword(s):  
Drug Regulation

scholarly journals FACTS ON DRUG REGULATIONS

2018 ◽  
Vol 2 (3) ◽  
pp. 43-47
Author(s):  
Rajkumar Gupta
Keyword(s):  
Life Cycle ◽  
Drug Regulation ◽  
Pharmaceutical Products ◽  
Regulatory Requirements ◽  
Ministry Of Health ◽  
Drug Products ◽  
Drug Regulations ◽  
The Law ◽  
Basic Facts

The pharmaceutical products are very much driven by the drug regulation imposed by ministry of health in individual countries. The basic facts on regulations is that they are mandatory and noncompliant are punishable under the law. Further, compliance is not a one time job but it is an exercise to be performed over the life cycle of the drug products. It starts from development of the products and continues till the product is in market. The information, registration, permission and extensions/withdrawals are the primary regulatory requirements for the drug products. The main focus of drug regulations is to check that safety, quality and efficacy of the drug products over its lifecycle.

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