Tagged with EG

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…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? Iraq has faced considerable challenges in its healthcare system due to years of conflict, instability, and underinvestment. As a result, there are ongoing discussions and proposals aimed at reforming the healthcare system to improve its quality, accessibility,…

Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In Iraq, Cannabinoid Drugs are generally not authorized due to strict drug control laws and cultural sensitivities around cannabis-related substances.   2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? The Ministry of Health and related drug regulatory…

Pharma Legal Handbook 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Localization policies in Iraq generally aim to encourage local production, increase employment, and reduce dependence on imported goods. These rules and regulations may not be…

Pharma Legal Handbook 1. What is the definition of Rare Diseases in your country? In Iraq, there is no specific definition of rare diseases in the legal or regulatory framework. The concept of rare diseases generally refers to conditions affecting a small percentage of the population, but an official definition may be absent…

Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? No, biosimilar medicines are not considered the same as generic medicines in Iraq. Generic medicines are chemically identical to their branded counterparts, while biosimilars are derived from living organisms and are similar but not identical to the…

Hong Kong Former Hong Kong SAR Chief Executive CY Leung  discusses Hong Kong’s unique positioning within the Greater Bay Area and the importance of its openness, international business mindset, and strong sense of social responsibility in maintaining its global relevance. Leung also reflects on Hong Kong’s response to political and economic uncertainties…

China Writing in the July 2024 edition of DIA’s Global Forum magazine Mingcan DU and Fengyun (Vicky) HAN of Johnson & Johnson Global Regulatory Policy and Intelligence look back at the evolution of the use of real-world evidence (RWE) in regulatory decision-making in China, including key use cases and future prospects.…

Africa The IFPMA’s Sarah Adam, writing in the July 2024 edition of DIA’s Global Forum magazine, looks back on an insightful discussion on the progress towards an African Medicines Agency at the DIA Europe conference earlier this year. The African Medicines Agency (AMA) is paving the way for Africa to achieve…

Hong Kong Andrea Chang, general manager of Eisai Hong Kong explains the importance of the firm’s FDA-approved Biogen-partnered Alzheimer’s disease (AD) product, particularly in Hong Kong where some 20 percent of the population is aged 65 or older. In addition, she outlines Eisai’s oncology and neurology-focused portfolio; the potential provided by Hong…