Tagged with J

Pharma Legal Handbook Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Marketing authorization holders of products designated as subject to the Cost-Effectiveness Evaluation System are required to conduct an analysis of the cost-effectiveness evaluation of the designated products and submit a report describing the analysis data. With…

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…

MEA The latest pharma and healthcare news from the dynamic Middle East and Africa market, which reached USD 32.6 billion in value last year according to IQVIA. With supply security of essential medicines and vaccines still a hot-button issue, Egypt and Morocco are establishing a regional biomanufacturing hub for North Africa.…

Ireland In the latest chapter of the trade disputes launched by Donald Trump, the US president has accused Ireland of “stealing” pharma tax revenue. The country’s low corporate tax rates have attracted American heavyweights like Pfizer and Eli Lilly in recent years, but could changes to tax policy and trade tariffs…

Saudi Arabia Michio Kondo, Fujifilm’s MEA managing director, discusses the company’s remarkable growth in the Middle East and Africa since 2022, highlighting key developments such as the acquisition of Hitachi’s imaging division in 2021, which expanded their product portfolio to include MRI, CT, and ultrasound equipment. Fujifilm has also strengthened its presence…

Asia A whistlestop tour though the latest news from pharma in Asia, taking in the American gene sequencing giant caught in the crosshairs of the US-China tariff row, the ADC-focused Singaporean biotech getting a 187 million dollar funding boost, why the Australian regulator has rejected Eisai’s Alzheimer’s drug, the activist fund…

Japan Japan was once a global leader in life sciences innovation, introducing about a third of the world’s new drugs in the 1980s, but this positioning slipped following decades of economic stagnation compounded by a conservative regulatory regime. However recent regulatory reforms have brought a more positive outlook and sparked a…

Japan Santen is on a mission to reshape the future of eye health. With three major product launches ahead, bold biotech deals, and a revamped global strategy, the Japanese pharma is doubling down on its ophthalmology dominance. Fresh off a transformational reorganization and a landmark myopia approval, Santen is proving that…

Mexico Whenever the international investor community contemplates doing business in Mexico’s life science sector, the primary appeal usually derives from the sheer size of the marketplace and its underlying growth potential associated with trends in the country’s population demographics. Much attention is thus given over to devising strategies to win public…