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Pharma Legal Handbook In addition to the clinical data obtained through clinical studies please list the data required for   a. Market approval In general, an applicant for marketing authorization for a new drug is required to submit the information and data below. Documents a. Origin or background of discovery, condition of use…

Pharma Legal Handbook Are there any Managed entry agreements in place in your country? (If so, please list them) No.   For each Individual Managed entry Agreement Describe the fundamentals of the Managed entry Agreement, its rationale and the process for implementing it. N/A   When should this Managed Entry Agreement be considered?…

Pharma Legal Handbook Which are the main actors involved in public procurement and tendering? Please see the response to Question II.-7.   What are the main characteristics of the public procurement and tendering system? Japan has established voluntary measures, such as tendering procedures based on stricter standards than those in the WTO-GPA, for…

Pharma Legal Handbook Please describe the main cost containment policies in place in your country and their fundamental principles   a. Pricing and impact of generic/biosimilar approval (i)  Pricing Generics and biosimilars are priced lower than their branded equivalents, reflecting lower R&D costs. When a generic drug is first listed on the NHI…

United Kingdom UK Prime Minister Keir Starmer’s government continues its push to overhaul the country’s iconic National Health Service (NHS). After originally announcing plans to restructure NHS England, the body that manages the NHS in England, it has now decided to eliminate it altogether. In a move that Starmer said would increase…

Spain A roundup of the biggest pharma news from Spain, including Grifols’ comeback after a turbulent 2024 when the company lost 30 percent of its market value; Almirall’s revenue and value surge; Rovi’s contract manufacturing downturn, and Lilly’s USD 50 million Madrid plant expansion.   Grifols expects to boost revenue and…

Saudi Arabia Mohamed Ayad, representing Santen as the Head of the Middle East, discusses the Japanese multinational firm’s growing presence and strategic focus in the region. He shares insights into the challenges and opportunities within the eye health care and ophthalmology market, Santen’s innovative approach to product offerings, and the company’s commitment…

Puerto Rico Añasco-based Techno Plastics Industries (TPI) is a Puerto Rican firm specializing in injection molding, producing high-quality plastic parts for industries like medical devices, electronics, and aerospace. Recently appointed General Manager, Jorge L. Cabrera Lázaro discusses the company’s priorities, technological advancements, and its vision for the future while sharing insights into…

Saudi Arabia Dr Ahmed Alaskar, Executive Director of KAIMRC, provides an update on the development of Saudi Arabia’s growing biotech ecosystem over the past four years. He shares insights into the Kingdom’s National Biotech Strategy and the development of early-stage clinical trial capabilities. Dr. Alaskar also highlights the Kingdom’s unique advantages in…

Saudi Arabia Dr Nasreen Alfaris, a leading Endocrinology, Diabetes, and obesity physician consultant in Saudi Arabia, shares insights into the evolving landscape of obesity medicine in the Kingdom. She discusses her role in establishing the Saudi Obesity Medicine Fellowship Program, the significant strides made in obesity awareness and treatment, and Saudi Arabia’s…

Saudi Arabia Cooper Pharma, with its 90-year legacy, is at the forefront of transforming the pharmaceutical landscape in the Middle East. From localizing production in Saudi Arabia to pioneering collaborations with global institutions, the company is driving innovation in a rapidly evolving market. As Saudi Arabia’s Vision 2030 reshapes the future of…

Saudi Arabia Neuroscience in Saudi Arabia is undergoing a quiet revolution. With unprecedented investment in research, cutting-edge clinical trials, and a push to redefine patient care, the country is rapidly positioning itself as a key player in global neurological advancements. From expanding access to specialized treatments to fostering cross-border collaborations, its ambitions…