The UAE has introduced a comprehensive new law to regulate medical products, pharmaceutical establishments and biobanks, aiming to strengthen oversight, enhance safety and encourage innovation across the healthcare and pharmaceutical sectors.

Declared on December 29, the law covers a broad spectrum of products and businesses including medical equipment, pharmaceutical and healthcare items, biological products, nutritional supplements, cosmetics and genetically modified organisms for medical use, As it also covers controlled narcotics, chemical precursors, and dangerous materials.

The law includes national biobanks as well as pharmaceutical facilities housed in free zones. Pharmacy chains, compounding pharmacies, pre-clinical and clinical research entities, marketing companies, pharmaceutical consulting firms, medical warehouses, medical stores, contract manufacturing organizations, factories, contract research and development organizations are among these establishments.

The law creates a strong basis for licensing, running, and supervising biobanks and pharmaceutical companies. It lists the obligations of important agencies like local health authorities, the Ministry of Health and Prevention, and the Emirates Drug Establishment, Handling functions including licensing for medical items, approving their import, export, and re-export, and certifying Good Practices in the pharmaceutical industry, the Emirates Drug Establishment is absolutely vital. Furthermore in charge of maintaining regulatory compliance are pharmaceutical manufacturers, marketing companies, and medical warehouses.

A key element of the law is the control of license for medical and pharmaceutical facilities. This covers specifying systems for assigning ownership and guaranteeing operator responsibility. Approval of the safe disposal of medicinal products, licensing of pharmacy experts, and monitoring facilities including pharmacy chains, compounding pharmacies, and medical stores falls to the Emirates Drug Establishment in concert with local health authorities, Though their operations are limited to storage, government hospital blood storage facilities are likewise under supervision.

The law also requires cooperation among pertinent agencies to consolidate databases, simplify information-sharing about issued licenses, and promote supervision of these institutions by means of coordination, With this integrated approach, it is hoped to guarantee a consistent regulatory framework and avoid holes in control.

The bill adds measures for intellectual property protection and regulatory exclusivity in order to encourage pharmaceutical sector innovation. It creates a fast-track system for conditional authorizations and emergency use of new medical items of therapeutic significance, therefore awarding marketing authorization, These clauses seek to draw money and support the evolution of innovative cures.

By means of national strategies for strategic inventory of medical products, the law seeks to increase UAE's readiness for health crises and guarantee the availability of required supplies, so stressing on reducing the negative effects of medicinal products and guaranteeing their safe use.

The law lays large fines for infractions in order to enforce compliance, Those businesses that disobey the rules risk fines of up to Dh1 million; individual practitioners might be penalized up to Dh500,000. Further disciplinary measures call for interim license suspension or cancellation and preventative closing of businesses.

Penalties for certain violations such as illegal development, distribution, or disposal of medicinal products are tiered, For instance failing to get licenses or marketing authorizations could result in fines; repeated infractions might cause compounded fines. These strict policies are meant to discourage behavior and uphold industry standards by means of high degrees of discipline.

From manufacture and development to marketing and disposal, the legislation covers a broad spectrum of actions inside the pharmaceutical and healthcare sectors. It controls pricing, distribution, and strategic inventory strategies as well as the issuing of marketing authorizations and exclusive licenses, The creation of the Pharmaceutical Policies Committee suggests policies for monitoring, pricing, and controlling medicinal items, therefore improving the application of the law.