Tagged with Pharm

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…

Global Originally seen as occasional service providers for the pharma industry, contract development and manufacturing organisations (CDMOs) have become vital strategic partners. Helping pharma and biotech companies advance their therapies through their outsourced services, CDMOs have demonstrated their ability to respond to the industry’s shifting priorities as well as its pre-…

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…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal, complementary, or alternative medicines and devices in Iraq are subjected to the regulations of Iraq Drug Regulatory Authority “IDRA” under the Ministry of Health “MoH”. Manufacturers or importers of these products must ensure…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? Iraq recognizes several types of liability, including: Product Liability: Relating to harm caused by defective products. Tort Liability: Involving personal injury or property damage due to negligence or other wrongful acts. Contractual Liability: Stemming from breach of contract or warranty.…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? Patent: To obtain a patent, the invention must be new (novel), involve an inventive step (non-obvious), and be capable of industrial application. In Iraq, the invention must be disclosed in a clear and complete manner. Trademark: To obtain…