Latest Articles

Preclinical & Clinical Trials in Panama are regulated by Law 78 November 20, 2003; Law 84 of May 14, 2019; Executive Decree 1110 June 6, 2012; Resolution No. 512 of June 28, 2019; Executive Decree 1843 December 16, 2014.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit)…
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? The Romanian law does not expressly provide such limitation as to the performing of clinical trials solely in Romania in view of obtaining the marketing authorization for a certain medicinal product.   2. How are clinical trials…
Preclinical & clinical trial requirements in Czech Republic – an overview. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted locally as a condition…
Preclinical and clinical trial requirements in Slovakian Pharma – a legal guide. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.   1. Are clinical trials required to be conducted locally as a condition (stated or…
Want to know about preclinical and clinical trial requirements in Peru? Read on! Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted locally as a condition (stated…
Preclinical & clinical trial requirements in Spain – a comprehensive legal overview. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted locally as a condition…
The low-down on the situation regarding preclinical & clinical trial requirements in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. Are clinical trials required to be conducted locally as a…
Preclinical and clinical trial requirements in Uruguay –  a legal guide. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit)…
The low-down on the situation regarding preclinical & clinical trial requirements in Malaysian pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.   1. Are clinical trials required to be conducted locally as a condition (stated…
The ins and outs of preclinical & clinical trial requirements: Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There…