06/10/2021
An intro to the legal situation for regulatory, pricing and reimbursement in Malaysia. 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 GDP 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Ministry of Health (MOH) is the primary governmental body responsible for the health of the people and the overall healthcare…
17/09/2021
Need to know about regulation, pricing and reimbursement in Colombian pharma? Read on! 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Jurisdiction over drugs, biologicals and medical devices is centralized at the Colombian National Food & Drug Surveillance Institute, better known as INVIMA.…
08/09/2021
The key legal info around regulation, pricing and reimbursement in Portuguese pharma. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Jurisdiction over drugs, biologicals and medical devices is centralized in Infarmed, the Portuguese Medicine Regulatory Authority (Autoridade Nacional do Medicamento e…
30/08/2021
An intro to the regulatory, pricing and reimbursement scenario for pharmaceuticals 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Several governmental agencies are responsible for the administration of drugs (including biologicals) and medical devices, including…
23/07/2021
An insight into regulatory, pricing and reimbursement overview in Czech Republic. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The main authorities with jurisdiction over drugs, biologicals, and medical devices in the Czech Republic are the Ministry of Health…
10/07/2021
An intro to the legal situation for regulatory, pricing and reimbursement 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The authorities responsible for applying and enforcing the regulatory framework shall be: concerning drugs and biologicals – the Ministry of Healthcare…
26/04/2021
An insight into regulatory, pricing and reimbursement overview 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The UAE Ministry of Health (MOH) is the primary authority responsible for oversight of all the regulatory functions concerning pharmaceuticals in the UAE. The Ministry…
20/04/2021
An insight into regulatory, pricing and reimbursement overview 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów…
30/05/2020
An intro to the legal situation for regulatory, pricing and reimbursement 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Vietnam, pharmaceutical products (including drugs and biologicals) and medical devices are under the overall management of the…
29/05/2020
All legal aspects surrounding regulatory, pricing and reimbursement 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. What are the Regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Regulatory authority is the National Institute of Hygiene. 2. What is the regulatory framework for the authorization,…
28/05/2020
An insight into regulatory, pricing and reimbursement overview 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Swiss Agency for Therapeutic Products (Schweizerisches Heilmittelinstitut [Swissmedic]): The Swiss Agency for Therapeutic Products (hereinafter: Swissmedic) is the competent authority for various…
27/05/2020
An insight into regulatory, pricing and reimbursement overview 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Ministry of Health and Care Services (nw. Helse-og omsorgsdepartementet, “HOD”) is the legislative authority. The Norwegian Medicines Agency (nw. Statens legemiddelverk…
04/02/2020
The key facts about regulatory, pricing and reimbursement overview 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Medicines Control Authority of Zimbabwe (MCAZ) is the authority tasked with regulation of drugs and medical devices in Zimbabwe. It…
03/02/2020
An intro to the legal situation for regulatory, pricing and reimbursement 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 USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authority in Ireland for drugs, biological and medical devices in Ireland is known as the Health…
23/01/2020
Regulatory, pricing and reimbursement overview in Italy – a legal guide. 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. What are the regulatory authorities with jurisdiction over drugs, biological, and medical devices in your country? The Italian Medicines Agency (Agenzia Italiana del Farmaco – “AIFA”) is the national authority vested with jurisdiction over medicinal products (including biologics).…
22/01/2020
An intro to the legal situation for regulatory, pricing and reimbursement 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Federal Agency for Medicines and Health Products (‘FAMHP’) is the competent authority for drugs, biologicals and medical devices in Belgium.…
19/01/2020
An insight into regulatory, pricing and reimbursement 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Population and Hospital Reform (“MSPRH” – “Ministère de la Santé, de la Population et de la Réforme Hospitalière”) is the national…
11/11/2019
All about regulatory, pricing and reimbursement overview 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Although the United Kingdom (UK) is negotiating its withdrawal from the European Union (EU), as of now, the UK remains…
09/11/2019
Regulatory, pricing and reimbursement overview in Thailand – a comprehensive legal overview. 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 USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Thailand, drugs, biologics, and medical devices are regulated by the Thai Food and Drug Administration (Thai FDA), under the…
06/11/2019
The key facts about regulation, pricing and reimbursement 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authorities with jurisdiction over drugs, biologicals and medical devices in Nigeria are: (i) The National Agency for Food and…
23/08/2019
Key legal info on regulatory, pricing and reimbursement in 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The following authorities are responsible for applying and enforcing the regulatory framework pertaining to drugs (including biologicals) and medical devices in Bulgaria: The Bulgarian Drug Agency (BDA) is a specialized State regulatory…
09/08/2019
An intro to the legal situation for regulatory, pricing and reimbursement in Japan. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) 2. What is the…
18/07/2019
Key legal info on regulatory, pricing and reimbursement in Spain. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The main regulatory authorities in Spain are: The Spanish Ministry of Health, Consumption and Welfare (‘Spanish Ministry of Health’), which is…
17/07/2019
The legal framework for regulatory, pricing and reimbursement of drugs in Denmark. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Danish Ministry of Health is responsible for defining the overall framework for the national healthcare system. As a governmental body…
02/07/2019
All you need to know about regulation, pricing and reimbursement in Nicaraguan pharma. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The National Health Regulation Authority (ANRS) has been created, which is the competent body of the Ministry of Health, which will…
An intro to the legal situation for regulatory, pricing and reimbursement in Slovakian Pharma. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In the Slovak Republic, the main regulatory authorities over medicinal products, biologicals, and medical devices are the State Institute for Drug Control…
30/06/2019
The legal framework for regulatory, pricing and reimbursement 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authorities competent in these fields are: the Ministry of Health (http://www.ms.ro/); the National Agency for Medicines and Medical Devices (https://www.anm.ro/);…
An intro to the legal situation for regulatory, pricing and reimbursement in Panamanian Pharma. 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. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Authority that regulates drugs, biologicals and medical devices in Panama is the Ministry of Health through the following authorities: Pharmaceutical…
29/06/2019
A brief overview of the situation regarding regulatory, pricing and reimbursement of drugs in Luxembourg. Prepared in association with Wildgen, a leading global law firm, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Within Luxembourg, the regulatory authority in charge of the matter of drugs, biologicals, and medical devices is the Ministry of…
The key facts about regulatory, pricing, and reimbursement of drugs in Indonesia. 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 USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authorities with specific jurisdiction over drugs, biologicals, and medical devices in Indonesia are: a. Ministry of Health of the Republic of…
28/06/2019
An intro to the legal situation for regulatory, pricing, and reimbursement of drugs 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Federal Ministry for Health (Bundesministerium für Gesundheit (BMG), Berlin and Bonn). https://www.bundesgesundheitsministerium.de/ Drafting legislation, regulations and ordinances…
An insight into regulatory, pricing, and reimbursement of drugs in Egypt. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The pharmaceutical regulatory body in Egypt is the Egyptian Drug Authority (EDA) operating and working under supervision of the Ministry of…
27/06/2019
An intro to the legal situation for regulatory, pricing and reimbursement of drugs in Croatia. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in Croatia is the Agency for Medicinal products…
26/06/2019
A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Chile. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Chile the regulatory authority responsible for the enforcement of the regulatory framework for pharmaceutical products, including biologicals, and medical…
01/03/2019
All about regulation, pricing and reimbursement in Singaporean pharma. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The key regulatory authority with jurisdiction over drugs, biological and medical devices in Singapore is the Health Sciences Authority (HSA). It was established on 1 April 2001 as…
15/02/2019
A legal intro to the situation regarding regulation, pricing and reimbursement in Greek pharma. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The National Organization for Medicines (hereinafter referred to as E.O.F.) which was established in 1983 as a public entity…
12/02/2019
An overview of the regulation, pricing and reimbursement of drugs in Bolivia. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Bolivia the authority that regulates all matters is the State Agency for Medical Products and Health Technology (Agencia Estatal de Medicamentos y…
08/02/2019
An intro to the regulatory, pricing and reimbursement scenario for pharmaceuticals in Peru. 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 75. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Drugs, biological and medical devices are regulated by the Directorate General of Medicines, Supplies and Drugs – (known in Spanish as…
28/01/2019
A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Canada. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Health Canada is the federal authority responsible for regulating pharmaceutical drugs, biologicals, and medical devices for human use. Health Canada’s…
23/01/2019
A brief legal overview of the situation regarding the regulation, pricing and reimbursement of pharmaceuticals 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 75, here. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Brazil, the authorities are the National Health of Surveillance Agency (“ANVISA”),…
08/11/2018
All about regulation, pricing and reimbursement of drugs in Lithuania. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The authority responsible for applying and enforcing the regulatory framework and performing control functions in relation to drugs and biologicals is the State Medicine…
A brief overview of the situation regarding regulatory, pricing and reimbursement 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? There are several authorities responsible for applying and enforcing the regulatory framework in relation to drugs, biologicals, and medical devices:…
07/11/2018
All legal aspects surrounding regulatory, pricing and reimbursement 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The authority with jurisdiction over medicines and biologicals is the State Agency of Medicines (SAM). The authority responsible for applying and enforcing the…
06/11/2018
A brief overview of the situation regarding regulatory, pricing and reimbursement in Uruguay. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The authority responsible for applying and enforcing the regulatory framework in relation to drugs, biologicals and medical devices is the Ministry…
An intro to the legal situation for regulatory, pricing and reimbursement in Turkey. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Turkey’s Ministry of Health (“Ministry”) is the main regulatory and responsible authority for drugs, biologicals and medical devices. Regulatory authorities with jurisdiction…
25/10/2018
An intro to the legal situation for regulatory, pricing and reimbursement 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 USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? the Ministry of Health of Ukraine (“Ministry”) the State Service of Ukraine on Medicines and Drugs Control (“SSM”) the National…
12/10/2018
An insight into regulatory, pricing and reimbursement in South African Pharma. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The South African Health Products Regulatory Authority (SAHPRA), previously known as the Medicine and Control Council (MCC). 2. What is the regulatory…
11/10/2018
All about regulation, pricing and reimbursement in Indian pharma. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The following authorities are responsible for the regulation drugs, biologics and medical devices in India: (i) Central Drugs Standard Control Organization (“CDSCO”),…
Important legal info for regulatory, pricing and reimbursement in Mexican pharma. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in Mexico? The authority responsible for applying and enforcing the regulatory framework in relation to drugs, biologicals, and medical devices is the Federal Commission for Protection against…
29/08/2018
All you need to know about regulation, pricing and reimbursement in Ecuadorian pharma. 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. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The authority responsible for applying and enforcing the regulatory framework in relation to human medicines, biologicals, and medical devices is the…
09/08/2018
A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Argentina. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The National Ministry of Health (“MoH”) is the main health authority in Argentina. Nonetheless, in the year…
08/10/2019
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