A central element of this pharma sector investment initiative is the introduction of advance purchase agreements that can cover up to 30 per cent of the Ministry of Health’s requirements for locally manufactured pharmaceutical products. As the Sultanate of Oman’s largest customer for medicines and pharmaceutical products, the Ministry of Health represents a significant and predictable source of demand for companies establishing production capacity in the country.

Oman is also providing price-based support, including a price preference of up to 30 per cent for locally manufactured products and 20 per cent for products undergoing secondary packaging. These measures are intended to strengthen the competitiveness of Oman-made medicines in government procurement while encouraging investors to shift from importation towards domestic manufacturing.

Pharmaceutical Projects Expand Across Oman’s Economic Zones

OPAZ said the incentive package to attract pharma sector investment is part of a wider strategy aimed at positioning Oman as a regional centre for pharmaceutical and medical industries.

The authority stated, “Oman’s pharmaceutical industry is accelerating, powered by a business-friendly investment environment, competitive incentives and diverse investment opportunities.”

The country already has 13 pharmaceutical projects and manufacturing facilities spread across its special economic zones, free zones and industrial cities. These projects cover areas including generic pharmaceutical manufacturing, research laboratories, active pharmaceutical ingredient (API) production, vaccines and biopharmaceuticals.

OPAZ further said, “13 pharmaceutical projects and manufacturing facilities across Oman’s Special Economic Zones, Free Zones and Industrial Cities — offering investors a strategic platform to scale and grow.”

The range of opportunities is also being extended to medical devices, including medical equipment, digital health solutions, surgical instruments and smart health-monitoring devices.

Tax, Customs and Foreign Ownership Benefits

The investment package includes several financial and ownership-related incentives designed to support companies establishing operations in Oman. Investors can receive tax exemptions for up to 30 years, while customs exemptions are available on raw materials and equipment. The framework also carries no minimum capital requirement and permits 100 per cent foreign ownership.

OPAZ additionally highlights exemptions from personal income tax, value-added tax and capital gains tax. Alongside these financial measures, investors can access streamlined establishment and licensing procedures, work permits issued within 24 hours, long-term residency visas and the ability to transact in all currencies. Usufruct agreements can run for up to 50 years and are renewable, providing investors with longer-term operating arrangements.

Investor Support and Infrastructure

OPAZ said companies entering the sector will also benefit from one-stop-shop services, dedicated investor-support teams, flexible regulatory procedures and accelerated customs clearance. Infrastructure and facilities can be tailored to individual requirements, providing additional support for pharmaceutical and medical device producers establishing operations within Oman’s special economic zones, free zones and industrial cities.

OPAZ added, “With the right infrastructure, strategic advantages and an enabling investment ecosystem, Oman is emerging as a regional hub for medical and pharmaceutical industries, creating new opportunities for investors and driving sustainable industrial growth.”

Market Expansion and Technology Investments

The pharmaceutical sector is defined as a high-technology industry requiring substantial capital investment and intensive research initiatives. Beyond creating treatments for medical conditions, companies operating in this space continuously develop products to improve overall quality of life. Within this framework, an originator pharmaceutical firm focuses heavily on research efforts to introduce patent-protected reference drugs. These capital allocations foster immediate product diversity and facilitate long-term competitive balance between originator and generic drugs.

During this same period of the 8-fold surge in R&D spending, the total pharmaceutical market size in Türkiye expanded from TL 56 billion in 2020 to TL 479 billion last year. The 8-fold growth in R&D spending, reflecting a 723% increase over five years, aligns with rising commercial activity across the country.

Global Context and Domestic Share

On a global scale, R&D spending on drug development grew by 3% in 2025 to reach $201.3 billion. The United States led international research expenditure at $130.1 billion. In terms of commercial reach, the world’s top 50 pharmaceutical companies by sales accounted for 88% of the U.S. market and 49% of the Turkish pharmaceutical market last year. This demonstrates that while global enterprise maintains a substantial presence in Türkiye, domestic and other international entities retain strong positions.

Strategic Focus under the Development Plan

Türkiye’s healthcare manufacturing structure is characterized by high value-added production and a skilled workforce. Under the framework of the 12th Development Plan, official policy aims to boost domestic production capacity, decrease reliance on foreign suppliers, and enhance national capabilities to manufacture innovative medicines.

Operational data from the 2020–2025 period indicates that products manufactured through local domestic production captured a larger share of the overall market than imported pharmaceutical products, measured both by total sales value and package volume.

According to industry sources, leading domestic pharmaceutical companies have recently secured product approvals as well as large-scale supply agreements across major Latin American countries, including Brazil and Mexico. The portfolio of products being introduced into the region continues to expand beyond aesthetic and plastic surgery offerings such as botulinum toxin to include prescription medicines and advanced digital healthcare solutions. This broader product mix reflects the growing importance of the Latin American market in the overseas expansion strategies of South Korean pharmaceutical companies.

Companies Broaden Regional Footprint Through Local Partnerships

Dongkook Pharmaceutical is moving into the Latin American prescription drug segment with an incrementally modified new drug combination product. The company signed a license and supply agreement with Spanish pharmaceutical company Faes Farma for the benign prostatic hyperplasia treatment ‘Uresco Tablets’. The contract is worth a total of W3.90 billion ($2.83 million) over the next 10 years. Under the agreement, the company plans to sequentially launch the product in 13 Latin American countries including Mexico and Chile and target the local chronic disease market.

Daewoong Pharmaceutical is also strengthening its presence in the Latin American market through its self-developed botulinum toxin product ‘Nabota’. In January, the company reinforced its regional position by signing an export contract for Mexico worth W2.95 billion ($2.14 million) with Latin American partner M8. As a result, Nabota has established a presence across all five of Latin America’s leading aesthetic and plastic surgery markets, including Brazil, Argentina, and Colombia. The company has also expanded its prescription drug business in the region after its diabetes treatment ‘Enblo’ received product approval in Mexico, increasing the number of Latin American countries where the treatment has obtained approval to seven.

Expansion efforts are extending beyond conventional pharmaceuticals into digital healthcare technologies. Dong-A ST entered into a distribution agreement with Cardios, a Brazilian company specializing in cardiac monitoring, for the wearable remote patient monitoring solution ‘HiCardi Plus’. The patch-type solution is capable of measuring electrocardiograms and respiration in real time and is scheduled to be supplied throughout Brazil using local hospital sales networks.

Industry sources indicate that the approach adopted by Korean pharmaceutical companies for the Latin American market has shifted significantly from simple export-driven business models toward locally embedded strategies. Rather than relying solely on overseas shipments, companies are increasingly collaborating with partners that possess extensive knowledge of local market conditions. This strategy enables them to navigate regulatory requirements more effectively while simultaneously establishing distribution infrastructure that supports faster market entry.

The signing of the agreement boosting Egyptian pharma export took place during an official visit by a high-level Djiboutian delegation led by Hibo Bacha, Chairperson of Bacha Group, Vice Chairperson of the Egyptian-Djiboutian Business Council, and President of the Djiboutian Businesswomen Association. Bilateral talks centered on advancing strategic cooperation in healthcare, reinforcing historic diplomatic ties, and supporting sustainable development initiatives across the continent.

Strategic Accord to Enhance Regional Pharmaceutical Security

As part of the delegation’s itinerary, Gypto Pharma demonstrated its integrated manufacturing infrastructure and modern production facilities. These sites operate in full compliance with international quality benchmarks and Good Manufacturing Practices (GMP). Delegations from both sides evaluated the specific healthcare requirements of Djibouti and neighboring countries to facilitate product registration and enable the direct distribution of essential pharmaceuticals.

Beyond pharma export agreements, the discussions outlined plans to gradually localize selected components of the pharmaceutical manufacturing process. This effort will leverage Bacha Group’s established logistics and industrial center in Djibouti, aiming to reinforce regional supply chains, optimize value chains, and promote deeper industrial integration.

Manufacturing Integration and Direct Supply Expansion

The strategic Partnership utilizes Djibouti’s position as a trade and logistics gateway connecting African, Arab, and global markets. This location serves as an entry point for delivering Egyptian medicines to member states of the Intergovernmental Authority on Development (IGAD) and the broader Horn of Africa.

Amr Mamdouh, Chairperson and Managing Director of Gypto Pharma City, stated that the Gypto Pharma Partnership is a key step in expanding Egyptian-African industrial ties. He emphasized that delivering safe and effective treatments forms the bedrock of healthcare security, identifying Djibouti as a pivotal regional trade partner.

Hibo Bacha commended the technological and manufacturing standards at Gypto Pharma, noting that the agreement supports the delivery of reliable healthcare solutions to East Africa. She added that both organizations aim to convert the memorandum into operational projects that strengthen economic collaboration and long-term pharmaceutical security.

The framework builds upon WHO’s Greener pharmaceuticals’ regulatory highway call to action, introduced in 2024, following an extensive process involving evidence gathering and consultations with regulatory authorities, manufacturers, international organizations, standards-setting bodies and technical experts from around the world. It highlights how regulators can utilize existing tools—including standards, scientific guidance, reliance, digital transformation and innovative regulatory pathways—to encourage wider adoption of lower-carbon technologies while continuing to safeguard patients.

Dr. Rogério Gaspar, Director of WHO’s Department of Regulation and Prequalification, said, “The question is no longer whether pharmaceutical decarbonization is possible. The real challenge is how quickly and equitably we can make it a reality.”

“This framework demonstrates how medicines regulators can create the conditions for innovation to flourish while continuing to uphold the highest standards of quality, safety and efficacy. By making full use of existing regulatory tools, they can help advance more sustainable pharmaceutical systems that benefit both people and the planet,” he added.

Framework Outlines Regulatory Measures To Support Lower–Carbon Pharmaceutical Systems

WHO noted that health systems account for around 5% of global greenhouse gas emissions, with pharmaceutical products contributing significantly throughout their lifecycle, including raw material sourcing, manufacturing active ingredients, packaging, distribution, use and disposal. At the same time, climate change continues to disrupt health systems and pharmaceutical supply chains globally. Recognizing that many technologies and solutions required for pharmaceutical decarbonization are already available, the framework emphasizes creating regulatory conditions that encourage broader and more consistent adoption without introducing delays, fragmented requirements or barriers to access.

To achieve this, the framework is structured around three interconnected pillars:

• The first focuses on awareness and capacity building by encouraging climate literacy within existing regulatory training programmes and improving regulators’ ability to identify emissions hotspots across pharmaceutical portfolios while strengthening knowledge exchange through existing global and regional regulatory networks.
• The second pillar addresses guidance, tools and standards by recommending stronger international alignment in measuring, reporting and comparing pharmaceutical emissions through recognized standards, common methodologies and voluntary reporting mechanisms to improve transparency, consistency and reduce duplication for regulators and manufacturers.
• The third pillar concentrates on innovation and innovative regulatory pathways through expanded digital regulatory services, greater access to early scientific advice, streamlined sustainability-related post-approval changes, collaborative regulatory approaches and stronger reliance mechanisms, allowing environmentally beneficial innovations to move more efficiently through regulatory systems without compromising oversight.

Implementation Strategy Prioritizes Collaboration, Equity and Global Participation

The framework is the outcome of literature reviews, stakeholder consultations, horizon scanning and discussions held during WHO’s Global Regulators Summit in June 2026. These activities established broad international agreement that pharmaceutical decarbonization will require coordinated efforts involving regulators, manufacturers, procurement agencies, governments, standards-setting bodies, multilateral organizations, researchers and civil society.

Rather than establishing new institutions, WHO intends to implement the framework through existing international and regional platforms while working closely with national regulatory authorities, regional networks, the International Coalition of Medicines Regulatory Authorities, the International Council for Harmonisation and other partners to encourage knowledge sharing, pilot initiatives and greater regulatory alignment.

WHO further emphasized that the transition towards greener pharmaceuticals should remain just and inclusive through capacity building, technology transfer, sustainable financing and international collaboration. Looking ahead, the organization will continue working with regulators and partners worldwide to implement the framework through pilot projects, updated guidance, strengthened reliance mechanisms, capacity building and continued international dialogue to ensure future health products remain safe, effective, accessible and aligned with the goals of a healthier planet.

Karim Mikhail, B. Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER), highlighted the importance of the approval, stating, “Patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other austere environments may now have faster access to plasma when conventional frozen plasma is unavailable.”

“This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure,” he added.

Developed from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments, Ezplaz is a freeze-dried (lyophilized) plasma product available in Group AB and Group A with low-titer anti-B blood types. These blood groups were selected to reduce the risk of transfusion before a patient’s blood type has been identified during emergencies.

Unlike conventional plasma products that require frozen storage followed by thawing before use, this freeze-dried plasma product can be stored at room temperature, withstand temperature fluctuations, and be rapidly reconstituted when needed. It is supplied in a plastic bag instead of a glass bottle, lowering the possibility of breakage during transportation and handling. According to the FDA, these characteristics make Ezplaz well suited for use in austere environments, including combat zones, remote locations, and disaster response operations.

The product is indicated for adult patients requiring plasma when alternative plasma products are unavailable, including bleeding patients, patients needing massive transfusion, or certain patients on warfarin who are bleeding. Each Ezplaz kit contains one unit of freeze-dried plasma sealed in an outer foil pouch, one 250 mL bag of sterile water for injection, one sterile fluid transfer set, and one sterile blood transfusion set.

FDA Highlights Scientific Review and Military Collaboration Behind Approval

Commenting on the approval, Anne Eder, M.D, Ph.D., Director of the Office of Blood Research and Review (CBER), said, “This licensure demonstrates that innovation and rigorous scientific review can advance together, expanding treatment options and novel blood components while maintaining FDA’s standards for safety, purity, and potency.”

The approval follows efforts initiated under Public Law 115-92, enacted in December 2017, which authorized the DoD (now DoW)-FDA collaboration to help accelerate the development and review of products intended for serious or life-threatening conditions affecting American military personnel. As part of that initiative, the FDA issued guidance in 2019 to support manufacturers developing dried plasma products for transfusion.

After reviewing the available data, the agency concluded that, for the approved uses, the benefits of the freeze-dried plasma product outweigh its risks. The FDA noted that the safety profile of Ezplaz is consistent with other plasma products used for transfusion, while emphasizing that patients and healthcare providers should remain aware of transfusion-related risks and that healthcare providers should review the complete prescribing information before administration. The biologics license for Ezplaz was granted to Vascular Solutions, LLC, a subsidiary of Teleflex.

The inauguration ceremony, held in the Ismailia Public Free Zone, was attended by prominent government officials, including Minister of Industry Khaled Hashem, Deputy Prime Minister and Minister of Health and Population Khaled Abdel Ghaffar, Minister of Investment and Foreign Trade Mohamed Farid, and Ismailia Governor Nabil Hasaballah, among others.

Minister Hashem emphasized that the new facility represents a strategic advancement in localizing the production of rapid diagnostic tests. These tests are crucial for detecting infectious diseases and epidemics, facilitating drug screening, and identifying cancer biomarkers. The project aims to leverage Egypt’s strategic location and industrial infrastructure to establish the country as a regional hub for medical and diagnostic manufacturing.

The establishment of this domestic manufacturing capability is projected to lead to annual import savings of approximately $30 million. Furthermore, it is expected to create new avenues for exporting higher-value medical products. Minister Hashem noted that this initiative reflects a growing confidence in the capacity of Egyptian manufacturers to produce advanced medical goods that adhere to international quality standards.

This venture underscores the importance of collaborative efforts between various ministries, including Industry, Health and Population, and Investment and Foreign Trade, along with the Egyptian Drug Authority and the private sector, in strengthening Egypt’s pharmaceutical and medical industries.

Industrial development remains a cornerstone of Egypt’s economic growth strategy, with pharmaceuticals identified as one of seven priority sectors within the nation’s updated industrial strategy. This strategy prioritizes enhancing product quality, increasing local content, promoting technological modernization, attracting technology-transfer-based industrial investments, and integrating Egyptian industries into global value chains. The Ministry of Industry continues to implement measures aimed at improving the investment climate, including streamlining procedures and providing support for expanding production capacity and technological capabilities.

Following the inauguration, attendees toured the new production line, observing the advanced manufacturing technologies employed in the creation of rapid diagnostic tests.

The meeting, which lasted nearly 12 hours, featured differing viewpoints between FDA staff and several members of the advisory panel. FDA officials argued against expanding pharmacy compounding of the seven peptides under review, citing limited evidence regarding their safety and efficacy. In contrast, several panel members—many of whom have ties to the peptide industry and could potentially benefit from wider availability—supported broader access.

The panel’s endorsement of these peptides, which are built from the same building blocks the body uses to make proteins, represents a significant development for Health Secretary Robert F. Kennedy Jr., who has publicly supported peptide use, as well as for biohackers, wellness influencers and online communities that have actively promoted them.

Although unapproved versions of these peptides are already widely sold online through unregulated gray-market channels for purposes ranging from muscle recovery to longevity, analysts estimate that a legitimized peptide market could be worth between $2 billion and $3 billion, creating major opportunities for the telehealth industry.

FDA Staff and Panel Debate Safety, Quality, and Oversight

During Thursday’s discussions, several panelists questioned whether compounders would be required to submit safety data if the peptides were added to the list permitting pharmacy compounding for patients with a prescription. FDA staff responded that the panel itself does not have the authority to direct the regulator and indicated that the FDA’s investigational new drug application pathway would instead serve as the mechanism for monitoring safety of the peptide compounds.

Addressing the panel on Friday, Mary Thanh Hai, director at the Office of New Drugs, emphasized the distinction between compounded products and FDA-approved medicines. “Because compounded drugs are not FDA-approved drugs, the statutory requirement for substantial evidence of effectiveness is not applied to these products,” she said in her opening remarks.

“That said, for any physician prescribing a compounded product, one would think that it’s important that the question is asked, wouldn’t we want to know if the ‌drug works,” she added.

Concerns also extended beyond safety to the quality standards and common naming conventions associated with peptide compounds. Both panel members and participants from the public highlighted the need for clearer regulatory safeguards during Thursday’s proceedings.

On Friday, FDA staffer Russell Wesdyk addressed those issues directly, stating, “We lack the regulatory authority that put those guardrails in place…Even before I can get to putting quality guardrails in place, we’ve got to establish ‌an identity. So that’s what I’d ask you to think about as we go through these votes today.”

On the first day of the meeting, panel members narrowly voted in favor of allowing the unapproved peptides BPC-157, KPV, TB-500 and MOTs-C to be compounded by pharmacies for patients with a prescription. The discussions have also drawn attention to concerns over potential bias because of several panelists’ affiliations with the peptide industry. However, the health department has stated that all members underwent the same ethics review and vetting process required of FDA advisory committee members before participating in the proceedings.

Under the proposed framework, distributed manufacturing establishments would continue operating with a central quality oversight hub connected to multiple equivalent manufacturing units across different locations. Existing regulations require every manufacturing unit within such a network to complete a separate registration, resulting in administrative complexity. Through the proposed drug manufacturing registration changes, these distributed manufacturing establishments could instead register as a single establishment. The proposal would also allow manufacturing units to be added, relocated or removed using a streamlined update process. In addition, companies would be required to notify the FDA before relocating any manufacturing unit, addressing a gap in the agency’s real-time oversight capabilities.

“The FDA is proposing changes to our establishment registration regulations that would reflect how distributed manufacturing actually works — as one single establishment,” said Michael Davis, M.D., Ph.D., Acting Director of FDA’s Center for Drug Evaluation and Research.

“The proposed changes would make it easier for innovative manufacturers to operate efficiently, and give the FDA a clearer, more accurate picture of how and where drugs are being made,” he added.

Proposal Clarifies Foreign Registration Requirements and Supply Chain Visibility

Beyond domestic manufacturing, the proposed rule also addresses drug manufacturing registration and drug listing obligations for certain foreign drug manufacturing establishments. At present, some foreign establishments that manufacture drugs, including components of drugs such as active pharmaceutical ingredients, exclusively for distribution to other foreign establishments may not be registered with the FDA.

According to the agency, this limits visibility into upstream supply chains. By aligning the regulations with statutory requirements, the proposed rule would make it clear that these establishments are required to register with the FDA and report the drugs they manufacture. The agency says this would improve its ability to identify and respond to potential safety concerns affecting the supply chain.

If the proposed rule is finalized, the FDA expects it to lower registration costs for distributed manufacturing companies while creating long-term efficiencies for both the pharmaceutical industry and the agency. The proposal also builds on a series of administration actions focused on revitalizing American pharmaceutical manufacturing, strengthening supply chain transparency, and reducing vulnerabilities across the drug supply chain.

The BARBARA platform brings together 180 existing dementia research databases and population health studies into a single system designed to identify suitable participants for clinical trials more efficiently. By consolidating these research resources, pharmaceutical companies can more rapidly recruit appropriate clinical trial participants, while individuals living with dementia, as well as those considered at high risk of developing the condition, can be matched with studies suited to their circumstances.

Commenting on the initiative, James Bethell, chair of the BARBARA project steering committee and former U.K. Minister for Innovation at the Department of Health and Social Care, said, “BARBARA will be the world’s leading dementia data registration system for corporations seeking to test treatments.”

Focus on Accelerating Drug Development and Research Investment

Worldwide, 158 Alzheimer’s treatments are currently under development through 192 clinical trials, while additional drug candidates targeting other forms of dementia are also progressing through research pipelines. Across the pharmaceutical industry, one of the most significant barriers to developing new dementia medicines continues to be the challenge of identifying and enrolling appropriate clinical trial participants. Former Minister Bethell noted that only 173 patients in England participated in late-stage, commercially sponsored Alzheimer’s clinical trials during 2024–2025.

To address this issue, the BARBARA platform has been designed to integrate research data from across the country, enabling pre-screening of potential trial participants and reducing recruitment timelines. The organizations supporting the project believe that combining the platform with early diagnostic technologies based on blood biomarkers (biological indicators that diagnose disease) will make it possible for individuals at high risk of dementia—even before symptoms appear—to participate in research studies. They also expect the system to contribute to the development of precision dementia treatments through genetic analysis.

Beyond supporting dementia drug development, the project’s backers also see the BARBARA platform as an important foundation for attracting global pharmaceutical companies to conduct clinical trials and expand research and development (R&D) activities in Britain. They believe the initiative could help strengthen the country’s life sciences investment environment following the recent conclusion by the National Institute for Health and Care Excellence (NICE) that the Alzheimer’s treatments lecanemab and donanemab were not sufficiently cost-effective in terms of expense.

The amount of funding allocated to develop the platform is expected to be announced later in 2026. Through the initiative, Britain intends to accelerate dementia drug development while positioning itself as a destination for global clinical trials and life sciences investment.