Biological Products Registration A Deep Dive into Dubai’s Regulatory Landscape

Biological Products Registration And Documents Required | Dubai | UAE

Biological Products Registration in Dubai: Biological medicinal products are produced by a living organism. They are differing from chemical medicinal products in many ways. The manufacturing process of a biological medicinal product is highly complex. A single minute process changes can result in significant differences in the clinical properties of the biological medicinal products, and the registration of this product is also a tricky one. Still, we have a piece of vast knowledge in handling all the matters. But firstly let’s have a look at the opportunities in this business:-

Biological, medical products have now become a buzz in the present-day. These days, organic items are utilized for healing conditions and disorder, including genuine ailment and hazardous conditions, for example, diseases, joint pain, rheumatoid, and so on. If we look at the forecast, there is a tremendous opportunity in this business. 

Biological Products Market Global Trends, Market Share, Industry Size, Growth, Opportunities, and Market have a great chance to grow from 2019 to 2029. Biological Products Market is estimated to value over billions by 2026 end and register a CAGR of over 14.7% during the forecast period 2020 – 2025. The report inductees from the outline of business surroundings and explain the commercial swift of chain structure.

These products are produced from different natural foundations like proteins, nucleic acids, or sugars or living things, including cells and tissues. Natural concentrates as the class of prescription in this tight sense have had a dynamic effect on various clinical fields, dominatingly, rheumatology and oncology additionally cardiology, dermatology, nervous system science, gastroenterology,

In maximum fields, the biological products have now adding primary therapeutic options for the treatment of lots of ailments.

Things to be considered while registering the biological products in Dubai:

According to the ICH harmonized tripartite guideline, biotechnological/biological products have to go through the Stability Testing of New Drug Substances and Products.

The Health Sciences Authority (HSA) is the licensing authority for medicinal products in Dubai. The Health Products Regulation Group (HPRG) of HSA regulates health products to ensure that their quality, safety, and efficacy meet globally.

 The licensing of medicinal products for sale and supply in Dubai, including pharmaceutical and biological medicinal products, is governed by constitutional requirements under the Medicines Act.

Pre-market evaluation is conducted to determine the risk versus benefit of medicinal products before registration and HAS adopted a risk-based approach with the application of current international guidelines, criteria, and scientific information.

Remembering the above concerns, the candidate ought to build up the best possible supporting dependability information for a biotechnological/natural item and consider numerous outer situations that can influence the item’s quality and transparency.

Registering Biological products? Don’t worry we will handle

All in one answer to all your queries.

UAE government has set a list of rules and documentation which one has to follow before registering Biological products.

The things one must keep in mind that before registering.

  • Trade Name of the Product.
  • Composition of the product
  • Shelf-life of the product with Storage conditions
  • A declaration that the item is openly sold in the nation of Origin
  • Samples of the item in its last bundle.
  • The applicant must have the certificate of Analysis of the same batch of the samples submitted for registration.
  • Logo, autograph, and stamp
  • Certificate issued by accustomed organizations and authorities.
  • The applicant ought to have a clinical store authorized by the Ministry of Health.
  • Approved from MOH Circular No. 20 for 2001 gave by the Director of Drug Control Department.
  • Legal company registration certificate issued by UAE / MOH drug control department 11 Submit BSE / TSE free license from the proficient authority in Country of Origin.

If the manufacture marketing authorization holder (MAH) & manufacturer has not been registered in the UAE ministry of health, then this must be done before a product can succumb for registration. 

Our Team will handle all the process for biological products registration in Dubai and guide you at every step. Click Here to Contact MSZ or Email to