03/05/2022
The requirements for conducting preclinical and clinical trials in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 99, here. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. 2. How are clinical trials funded? Clinical trials are funded by sponsors (an individual or legal entity, public or…
07/02/2022
All legal aspects surrounding preclinical and clinical trial requirements in Saudi Arabia. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: Saudi Arabia, available to purchase here for GBP 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? It is mandatory to inform SFDA immediately about any Suspected Unexpected Serious Adverse Reactions (SUSAR) as soon as possible, no later than…
02/01/2022
All legal aspects surrounding precinical and clinical trials in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? For the purpose of obtaining marketing approval, at least part of clinical trials should be conducted in Ukraine. Notably, in relation to medical products…
29/11/2021
Preclinical and clinical trial requirements in Indonesia – an overview. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for GBP 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials do not have to be conducted locally for applying for MAs. The applicants must provide clinical trials results to prove the…
03/11/2021
A brief overview of the situation regarding preclinical and clinical trial requirements in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for GBP 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials do not have to be conducted locally in order to gain marketing approval in…
28/10/2021
Preclinical and clinical trial requirements in Luxembourg – a legal guide. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99. *Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit)…
06/10/2021
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 or implicit) for marketing approval? Malaysia is actively developing its capability in all phases of clinical trials and there is currently no mandatory condition for…
17/09/2021
The key requirements for conducting preclinical and clinical trials in Colombia. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. INVIMA accepts clinical trials conducted abroad, if they sufficiently demonstrate safety and efficacy of the drug product. 2. How are clinical…
08/09/2021
Preclinical and clinical trials in Portugal – a legal guide. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials may be conducted abroad. In those cases, and whenever clinical trials are conducted outside the European Union, the applicant of the…
30/08/2021
The essential requirements for conducting preclinical and clinical trials in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. According to the Technical Guidelines Governing Acceptance of Drug Clinical Data from Foreign Studies issued by the…
23/07/2021
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 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials may be also conducted abroad. If a clinical trial was conducted in a country outside of…
10/07/2021
All about preclinical and clinical trial requirements in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Under the EAEU regulations, clinical trials are to be conducted in the EAEU in compliance with the Good Clinical Practice of the EAEU (approved by the…
26/04/2021
All legal aspects surrounding preclinical and clinical trial requirements in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, 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? It is not an established requirement to conduct the clinical trials for products locally. As previously established, clinical trials are only required when the…
20/04/2021
All legal aspects surrounding preclinical and clinical trial requirements in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, 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? No, there is no requirement to conduct clinical trials locally to receive marketing approval. 2. How are clinical trials…
30/05/2020
A brief overview of the situation regarding preclinical and clinical trial requirements in Vietnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, 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? By law, clinical research documentation for the purpose of obtaining the MA must conform to the…
29/05/2020
The key facts about preclinical and clinical trial requirements in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Yes. 2. How are clinical trials funded? Clinical trials are funded by those interested in obtaining…
28/05/2020
Key legal info on preclinical and clinical trial requirements in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials do not have to be conducted locally as a condition for marketing approval. 2. How are…
27/05/2020
A brief overview of the situation regarding preclinical and clinical trial requirements in Norwegian Pharma. Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? See [Regulatory, Pricing and Reimbursement Overview, Section 3 b)]; new medical products must undergo an evaluation of…
04/02/2020
All legal aspects surrounding preclinical and clinical trial requirements in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There is no such requirement. The Medicines and Allied Substances Control Act only requires that a medicine be registered. In…
23/01/2020
Key legal info on preclinical and clinical trial requirements in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. However, having conducted part of the medicinal product development (including clinical trials) in Italy may place the marketing authorization holder in a stronger…
22/01/2020
All legal aspects surrounding preclinical and clinical trial requirements in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials are not required to be conducted locally to receive marketing approval in Belgium. In order to obtain marketing approval, for new drugs,…
19/01/2020
The legal framework for preclinical and clinical trial requirements in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? The Health Law No 18-11, dated of 2 July 2018, replacing Health Protection and Promotion Law No 85-05, dated of 16…
11/11/2019
A brief overview of the situation regarding preclinical and clinical trial requirements in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There is no requirement to conduct clinical trials locally to receive marketing approval. The steps that have…
09/11/2019
Key legal info on preclinical and clinical trial requirements in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, 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? No, the clinical trial does not need to be conducted locally in order to obtain marketing approval. The Thai FDA only requests…
06/11/2019
All legal aspects surrounding preclinical and clinical trial requirements in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials are not required in all cases, clinical trials will be required to be conducted as a condition for marketing approval…
23/08/2019
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 is no requirement for clinical trials to be conducted locally as a condition for obtaining market authorisation. However, if the clinical trials have been conducted…
09/08/2019
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 USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Under the Pharmaceutical and Medical Device Act (PMD Act), in general, clinical trials for application of marketing authorization approval…
18/07/2019
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 USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trial may be conducted abroad. For those cases whenever clinical trials are conducted outside the European…
17/07/2019
Preclinical and clinical trial requirements in Denmark – an overview. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, 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? No, clinical trials are not required to be conducted locally as a condition for a marketing authorization. As a starting point, an application for…
02/07/2019
A brief overview of the situation regarding preclinical & clinical trial requirements in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, 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? It is not a requirement that they be done locally. 2. How are clinical trials funded? The Manufacturer Laboratory…
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 implicit) for marketing approval? No, clinical trials can also be conducted abroad. If the clinical trial is performed outside the EEA, the applicant for the…
30/06/2019
An intro to the legal situation for preclinical and clinical trial requirements in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, 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? The Romanian law does not expressly provide such limitation as to the performing of clinical trials solely in Romania…
Preclinical and clinical trial requirements in Panamanian Pharma – an overview. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75. Preclinical & Clinical Trial in Panama are regulated on Law 1 January 10, 2001; 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,…
28/06/2019
A brief overview of the situation regarding preclinical and clinical trial requirements in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? 1. In principle, pre-clinical and clinical studies and trials can be obtained from regulated and approved providers…
Preclinical and clinical trial requirements in Egypt – an overview. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, 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? Yes, as there is an Authority “Central Directorate for Research and Health Development”, which is responsible for the registration and approvals…
27/06/2019
Preclinical and Clinical Trial Requirements in Croatia – an overview. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials are not required to be conducted locally as a condition for marketing approval. 2. How are clinical trials funded? Clinical…
26/06/2019
Preclinical and Clinical Trial Requirements in Chile – a legal guide. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. Chilean legislation and regulations do not require for clinical trials to be conducted locally in order to file for or obtain a…
01/03/2019
The key facts about conducting preclinical and clinical trials in Singapore. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, there is no such express statutory requirement under Singapore legislation. 2. How are clinical trials funded? Clinical trials may be funded by pharmaceutical companies, hospitals,…
15/02/2019
The key requirements for conducting pre-clinical and clinical trials in Greece. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. Article 9 par. 3 of Ministerial Decision Δ.ΥΓ3α/Γ.Π. 32221/Government Gazette B 1049/2013, issued in application of Directive 2001/83/EC of the European Parliament and…
12/02/2019
Preclinical and Clinical Trials in Bolivia – an overview. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, it’s not a set condition. Studies issued by other countries are accepted. 2. How are clinical trials funded? The interested party is responsible for…
08/02/2019
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 USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Peruvian law only regulates clinical trials conducted locally. 2. How are clinical trials funded? Clinical trials are funded by…
28/01/2019
Preclinical and clinical trial requirements for pharma in Canada – a comprehensive legal overview. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There is no requirement to conduct local trials of a new drug to receive marketing approval. Rather, in order to obtain marketing…
08/11/2018
All legal aspects surrounding preclinical and clinical trials in Lithuania answered in this structured guide. Prepared in association with TGS Baltic, a leading law firm in Lithuania, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, there is no requirement for clinical trials to be conducted in Lithuania as a condition for marketing…
Important legal info on preclinical and clinical trial requirements in Latvia. Prepared in association with TGS Baltic, a leading law firm in Latvia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, there is no requirement for clinical trials to be conducted in Latvia as a condition for marketing approval. Following the national procedure,…
07/11/2018
All legal aspects surrounding preclinical and clinical trials in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials are not required to be conducted locally as a condition for marketing approval. Following the national procedure, clinical trials may be conducted…
06/11/2018
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) for marketing approval? No. 2. How are clinical trials funded? Clinical trials can be funded by a promoter (individual, company, institution or organization responsible…
Preclinical and clinical trial requirements in Turkey – a legal guide. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, 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? Clinical trials for drugs are regulated by the Regulation on Clinical Trials of Drugs and Biological Products. Clinical trials for medical devices are regulated…
12/10/2018
All about preclinical & clinical trial requirements in South Africa. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. Clinical Trials do not have to be conducted locally in order for the Regulator to register the product and market approval to…
11/10/2018
Preclinical and clinical trial requirements in India. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, 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? If the drug or biological satisfies the definition of new drug (see Chapter 1 Question 3 above for definition), or if a notified medical…
29/08/2018
Key info on preclinical and clinical trial requirements in Ecuador. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75. As a general introduction, Clinical Trials are regulated in Ecuador via Ministerial Agreement (MA) 0075-2017 related to regulations for the approval, development, monitoring and control of clinical trials. This regulation was enacted on June 30th, 2017. There are other rules and regulations which make…
09/08/2018
Preclinical and clinical trial requirements in Argentina – a legal guide. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. It is not a condition for marketing approval to conduct a clinical trial in Argentina (the approval of pharmaceutical…
25/10/2016
Conducting preclinical or clinical trials in Mexico? Get the legal lowdown here. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials for innovator biological products must take place in Mexico when the product is to be manufactured in Mexico. For products…
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