Tagged with EG

regulator The technical & RA director and the managing director of Qually Corporacion explain how authorized third partied act as an extension of the regulative body, Cofepris, helping to assure that generics obtain a certain standard before they are released on the market, that is why the main challenge is to…

regulator The president of the Turkish Drug and Medical Device Agency (TITCK) discusses new initiatives and reforms being carried out by his agency, including its work towards becoming a PIC/s member, and the introduction of several changes designed to accelerate timelines for GMP certifications and marketing authorizations.   You began your TITCK…

Thailand Servier Thailand’s general manager discusses the company’s competitive role in Thailand despite market challenges, the company’s ability to remain innovative and successful regardless of Thailand’s changing policies and Servier’s unique work culture.   Servier Thailand hopes to continue improving its service offerings in the local market by working closely with…

Romania The director of Romania’s national pharmaceuticals regulator outlines how his institution is embracing health technology assessment (HTA) capabilities and the transformative changes this will have on the local industry. He also speaks frankly about hot topics sweeping the sector: among them the pressing need for increased regulation of medical devices…

law firm One of the original market builders of the commercial law practice in Romania analyses the state of in-country legal firms in catering to the evolving needs of pharmaceutical industry players in a rapidly and radically transforming regulatory landscape. An expert in privatisation, he also explains why attempts to inject market…

Mylan The general manager of one of the world’s largest API manufacturers recalls the recent acquisition of Abbott by Mylan and the processes which he has undertaken to set his entity off along a new path. He also elaborates on the band consciousness of the Romanian consumer and how that affects…

government The pharmaceutical and medical devices industries are both classified as emerging sectors by the Ministry of Economy. The undersecretary of industry and commerce discusses the importance of the sectors to the Mexican economy and how the government is interested in transforming Mexico from a prevalently manufacturing-based into a more innovation-driven…

association The CEO of NAPM reveals how the main challenge facing his members is the length of time needed to register a generic product, taking up to four years and acting as a significant block on investment, discusses the benefits that come with being part of the International Generic Pharmaceutical Alliance…

government In public health everything is a priority. The Undersecretary of Prevention and Health Promotion explains how Mexico’s Ministry of Health is handling the country’s changing epidemiological profile without forgetting communicable diseases and other urgencies affecting the Mexican population. You have been reappointed as Undersecretary of Prevention and Health Promotion in…

cofepris The implementation of third authorized parties has been a very proactive effort implemented by Mexico’s regulatory authority Cofepris to expedite the time to issue sanitary registrations. The CEO of Entimem provides an overview about the system currently in place, the challenges faced as well as benefits such a system offers…

market access Many of the multinational companies with a long-standing presence in Latin America used to have factories in Peru – since the 1990s all of these companies have closed their facilities in the country as part of a consolidation process to other larger countries in the region like Mexico, Brazil or…

biotech Medytox is the most valuable pharmaceutical business in Korea, with a highly successful botulinum toxin product on the market, and can only grow further when they finish development of their second generation botulinum toxin product that will be commercialized globally (outside of Japan and Korea) by Botox manufacturer Allergan. What…