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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 The GBA Healthcare Group aims to provide accessible, affordable, and accountable healthcare in the Greater Bay Area through a public-private partnership model, focusing on primary healthcare and health insurance empowerment. Co-CEO Dr Felix Lee, who also serves as Head of Healthcare Investments at parent group Chow Tai Fook Enterprises Limited,…

Hong Kong Prof. Lo Chung-mau, Hong Kong’s Secretary for Health, delves into some of the key strategic initiatives for advancing Hong Kong’s healthcare and biomedical innovation. Key topics include the integration of the Greater Bay Area (GBA) for enhanced clinical trials, addressing the increasing needs of Hong Kong healthcare system, and leveraging…

Global Recently appointed ISPOR President Eberechukwu Onukwugha, PhD, lays out her inclusive vision for the organisation’s future, championing health economic and outcomes research excellence and innovation that works for all. The original version of this article featured in the July/August edition of ISPOR’s Value & Outcomes Spotlight magazine.   As I…

Hong Kong Derek Chang introduces some of the key therapeutic advancements Novartis has been able to introduce in Hong Kong, including cell therapy and siRNA therapies, and its ongoing focus on targeted radioligand therapies, which benefit from the territory’s robust legislative framework. Chang also touches on the importance of Hong Kong’s “1+”…