How to Register and Import Health Products in Dubai

To register and import health products in Dubai, suppliers must first obtain a valid trade license from the Department of Economic Development (DED).

Once the license is obtained, suppliers must then register with the Dubai Municipality and obtain a health product registration certificate. This certificate is required for the import of health products into Dubai.

Suppliers must submit an application to the Dubai Municipality, which includes details such as test results and other relevant documents. After the application is approved, suppliers can proceed with the import of health products into Dubai.

Steps for Import Permit and Shipment Clearance

Commercial Shipments

1. Visit the Dubai Municipality website – montaji.dm.gov.ae
2. Register the company on the website by creating an account.
3. Register the products (CPRE) for every item:
   • Login to your account.
   • Go to services and select Consumer Products Registration (CPRE).
   • Fill in the registration form with product details, including brand name, product name, barcode, country of origin, size, etc.
   • Upload the required documents.
   • Pay the fees (10 AED per product).
4. CPRE-2020-XXXX will be issued for each product submitted for registration.
5. If required, pay the security deposit of AED 15,000 through the Deposits service.
6. For the Import Request (CPIP):
   • Login to your account.
   • Go to services and select Consumer Products Import/Re-export (CPIP).
   • Fill in the form with consignment details.
   • Upload the documents (bill of entry, invoice, packing list, AWB, DO).
   • Pay the fees (70 AED per consignment).
7. CPIP-2020-XXXX will be issued for each consignment.

Oncology Drug Approvals - Q2 2021 Report

Key Insights from OncoHealth's Q2 2021 Report

OncoHealth, the main advanced health association focused on the physical, internal, and financial complications of cancer care, has released its Q2 2021 report detailing the FDA's latest approved oncology drugs. This report highlights the increase in accelerated approvals as well as emerging concerns regarding their development.

Accelerated Approvals and Safety Designations

OncoHealth's report reveals that 29 of the approvals featured a safe designated spot asset, while 43 were biomarker inferior. Fifty (seven of 14) new oncology drugs received accelerated approvals in this quarter, an increase from 36 in the same quarter of 2020.

Cost Trends

The costs associated with the drugs receiving accelerated approvals in Q2 2021 ranged from $404 to $336 annually. Over the past two years, the FDA has granted 38 accelerated approvals in oncology.

FDA's Approval Trends

"As the FDA increases its accelerated approvals, a significant number of new drugs are being granted with cautious optimism," stated the Senior Vice President of Pharmacy at OncoHealth. Concerns remain regarding delays in confirming primary issues and the lack of prompt action by the FDA during prior investigations.

FDA Activity Amidst COVID-19

Despite the focus on the COVID-19 pandemic in recent months, the FDA has continued to approve oncology-related drugs. The 14 approvals in Q2 contribute to a total of 34 oncology drugs approved in the first half of 2021, in addition to the 66 oncology-related approvals in 2020.

Emerging Treatments and Biomarkers

OncoHealth's Q2 2021 report also notes that immune checkpoint inhibitors continue to grow in usage, establishing their place as the standard of care in over 17 distinct cancer types. Nearly a third (29) of new oncology drugs in the second quarter of 2021 involved an immune checkpoint asset, up from 25 in the same quarter of 2020.

Trends in Drug Approvals

A notable trend is that one in four FDA approvals now contains a safe designated spot asset. In Q2 2021, 43 of the approved oncology drugs were biomarker inferior. Two of the seven new molecular entities (NMEs) supported in the second quarter of 2021 introduced new molecular targets for advanced/metastatic non-small cell lung cancer (NSCLC).

Future Directions in Oncology

Oncologists are increasingly turning to germline and tumor testing to better inform treatment decisions.

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Drug Regulatory Reforms in India

The proposed reforms in the existing drug regulatory system in India include provisions for manufacturing and stockpiling of non-COVID vaccines during clinical trials. The Health Ministry's May 18, 2020, announcement marked a significant change by allowing the stockpiling of COVID-19 vaccines during clinical trials, which accelerated the availability of vaccines for public distribution.

Impact on COVID-19 Vaccine Manufacturing

Due to this rule, it became possible to manufacture and stockpile the COVID-19 vaccine during its clinical trials. As a result, millions of vaccine doses were made available in a short span of time, saving countless lives. By the end of 2020, the Serum Institute of India (SII) had already produced around 50 million doses of the Oxford-AstraZeneca COVID-19 vaccine, even while waiting for regulatory approval.

Reforms for Non-COVID Vaccines

Given the success of this provision for COVID-19 vaccines, the same approach should be adopted for non-COVID vaccines. The authorization to use the remaining batches from clinical trials for commercial purposes would ensure that these vaccines are not wasted and can serve a greater purpose after proper regulatory approval.

Draft Rules and Future Implementation

In April 2018, the Health Ministry issued draft rules to allow the commercial use of remaining vaccine batches after clinical trials, under certain regulatory forms. However, these draft rules have yet to be implemented. Rapid enforcement of these rules is essential to prevent the destruction of life-saving vaccines.

Prime Minister's Vision for Regulatory Reform

Following Prime Minister Narendra Modi's vision, a high-powered inter-ministerial commission was established in May 2020 to reform India's drug regulatory system. Recommendations from this commission should be implemented quickly to improve the ease of doing business and advance India's global leadership in vaccine production.

Conclusion

The reforms in India's drug regulatory system, if implemented effectively, have the potential to elevate the country's vaccine industry to new heights. With the right regulatory framework, India can continue its role as a world leader in vaccine production and distribution.

Healthcare Regulatory Affairs Outsourcing Market Insights

The healthcare regulatory affairs outsourcing market is experiencing significant growth, driven by services to Clinical Research Organizations. Factors such as the rising number of patent expirations and increasing costs of research and development are influencing this expansion. Healthcare and biopharmaceutical organizations are likely to collaborate with outsourcing companies to get their drugs and devices approved in the global market. The approval process can be time-consuming, costly, and heavily reliant on documentation.

To address these challenges, service providers are focusing on outsourcing healthcare regulatory activities to reduce costs and specialize in core competencies. These regulatory service providers offer a range of services including pharmacovigilance, medical writing, and clinical trials to biotech companies across various countries. However, the market faces challenges such as price fluctuations and hidden expenses in regulatory services provided by different Clinical Research Organizations. High risks may also impact the productivity of the healthcare regulatory affairs outsourcing market.

Emerging economies, particularly in the Asia Pacific region, present lucrative growth opportunities for healthcare regulatory affairs outsourcing due to developing infrastructure and investments in healthcare technologies.

Global Healthcare Regulatory Affairs Outsourcing Market Overview

Regulatory policies are implemented to ensure that companies meet specific standards in their operations. In the healthcare industry, these policies aim to safeguard public health and welfare by ensuring the safety of pharmaceutical and healthcare products. Many healthcare companies are now outsourcing their regulatory functions to focus on their core competencies. The increasing number of medicines in the clinical development process is making regulatory affairs outsourcing more significant in the healthcare sector.

Trends and Opportunities

Healthcare institutes and pharmaceutical companies are increasingly outsourcing regulatory affairs to avoid high costs and leverage the expertise of contract research organizations (CROs). Outsourcing regulatory affairs allows these organizations to focus on their core competencies, which drives the growth of the global healthcare regulatory affairs outsourcing market. The benefits of outsourcing include cost-effectiveness, optimized reimbursements, faster product approvals, and increased market share and productivity. These factors contribute to the strong growth forecast for the market.

Regional Outlook

Geographically, the key market segments are Asia Pacific, North America, Europe, and the rest of the world. North America, led by the U.S., is the dominant region in the global healthcare regulatory affairs outsourcing market. Europe follows North America, with an emphasis on reducing investment costs and benefiting from lower labor costs. The focus on optimizing resources and accelerating product approvals is also prominent in Europe.

Emerging countries, particularly in Asia Pacific, are preferred for regulatory affairs outsourcing due to high costs in developed nations. Asia Pacific is experiencing impressive growth and is becoming a significant market for outsourcing due to its large pool of skilled labor at lower costs and the increasing number of pharmaceutical companies.

Vendor Landscape

Leading players in the healthcare regulatory affairs outsourcing market include Charles River Laboratories International, Inc., KAI Research, Inc., Medpace, Inc., and ICON Plc.

© 2024 Healthcare Regulatory Affairs Insights. All rights reserved.

Pharmaceutical Sales Before Marketing Authorization

When a patient has a serious illness and there’s no approved drug available, the physician might consider using a drug that has not been authorized for marketing but has shown promise in clinical trials. European Named Patient Programs, similar to US compassionate use programs, provide access to unlicensed pharmaceuticals. An important difference is that in Europe, unlicensed drugs may be reimbursed, allowing drug-makers to generate revenue while development is still in progress.

Significant Revenues Are Possible

The additional revenues from named patient programs can be considerable. For example, Pharmion, a US-based company specializing in Oncology and Hematology, reported a dramatic increase in Thalidomide sales from $1.9 million in Q2 '03 to $15.3 million in Q2 '04, primarily due to named patient sales in Europe. Thalidomide sales accounted for about 75% of Pharmion's total revenues in the first half of 2004.

Other Benefits of Named Patient Programs

A named patient program can speed up uptake after the official launch. Physicians who have experience with the drug before launch often become early adopters. Additionally, these programs can increase goodwill toward the company by simplifying access for patients in critical need.

Frequent Communication is Critical

To achieve success, it’s essential that physicians are aware of the product and know how to access it. A strong communication plan is necessary to keep the target health professionals informed.

Issues to Contemplate

If you decide to include a named patient program in your pre-marketing plan, consider whether to administer it internally or partner with an experienced organization. Proper administration can enhance program effectiveness and ensure compliance with regulations.

© 2024 Pharmaceutical Insights. All rights reserved.