Tagged with pharma

China The R&D-Based Pharmaceutical Association Committee (RDPAC) under the China Association of Enterprises with Foreign Investment (CAEFI) represents 46 multinational pharmaceutical companies with a strong R&D presence in China. Managing Director Renaud Gabay discusses how member companies are leveraging synchronized approvals to accelerate access; the evolution of China’s regulatory framework that…

China A roundup of some of the biggest China pharma industry stories, including the progress of the US Biosecure Act targeting Chinese biotechs; Innovent’s obesity and type 2 diabetes contender’s positive phase III trial results; the strategic partnership between Sino Biological and BioGeometry; CSL’s sale of its China-based plasma collection operations…

Switzerland Switzerland’s healthcare system is at a crossroads. Although still one of the world’s bastions of biopharmaceutical innovation, the country’s domestic healthcare environment is under increasing pressure from rising costs, mounting drug shortages, and a regulatory environment that is slow to adapt. What role could pharmacies and the off-patent industry play…

Switzerland Martine Ruggli discusses the evolving role of pharmacists in Switzerland’s healthcare system, addressing challenges and opportunities in digitalization, drug shortages, and regulatory reforms, as well as the need to leverage pharmacists’ expertise more broadly.   Investing in and empowering pharmacists is essential for improving the quality, accessibility, and efficiency of…

Saudi Arabia Saudi Arabia – by many measures the cultural, social, and economic epicentre of the Arab and Islamic worlds – is currently undergoing a once-in-a-lifetime transfiguration. The country’s ‘Vision 2030’ transformation plan has not only been radically reshaping the national economy and reducing its dependence on petroleum revenues but has also…

Europe Last year the European Commission (EC) came out with a proposal to reform the EU’s core pharmaceutical legislation, aiming to address affordability, accessibility, and availability, among other objectives. One of the key changes proposed was reducing the EU’s baseline regulatory data protection (RDP) timeline, a plan that pleased the generics…

China A roundup of top stories from China’s pharma industry, including BeiGene’s new US R&D and manufacturing facility; Merck’s purchase of investigational B-cell depletion therapy from Curon Biopharma, and the Chinese approval of AstraZeneca and Daiichi Sankyo’s gastric cancer therapy.   China’s BeiGene opens new clinical R&D and biologics manufacturing facility…

Hong Kong With its dual business approach – commercializing acquired products while developing a novel respiratory disease pipeline – Nuance Pharma, after closing Series D funding and establishing a solid revenue stream, has set its sights on Asia Pacific. Founder and CEO Mark Lotter, discusses the regulatory and talent acquisition challenges in…

Switzerland Switzerland, home to industry giants like Novartis and Roche, boasts a thriving pharma industry that generates some seven percent of the country’s GDP, as well as a flourishing biotech scene. However, all is not so well in Switzerland’s domestic healthcare landscape, where surging insurance premiums and drug costs mean that…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authority responsible for drugs, biologicals, and medical devices in Iraq is the Ministry of Health “MoH”. There is a dedicated body within the MoH known as the Iraq Drug Regulatory Authority…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? In Iraq, it is not always explicitly required that the clinical trials be conducted locally for marketing approval. However, if local data are requested, companies must comply with these requirements. Local clinical…

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? In Iraq, the authorization process for marketing new drugs, biologics, medical devices, over-the-counter “OTC” medications, and other medicinal products is managed by Iraq Drug Regulatory Authority “IDRA” at Ministry…