Regulation and Prequalification

Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.

About us

The Local Production & Assistance (LPA) Unit supports Member States in strengthening sustainable local production and technology transfer to improve access to safe, effective, quality, and affordable medicines and other health technologies, by applying a holistic, ecosystem-wide and strategic approach in collaboration with governments, partners, and other stakeholders. Local production has been discussed in World Health Assemblies since the 1970s. The adoption of Resolution WHA61.21for the Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property (GSPA-PHI), and recent WHA74.6 brought a renewed focus on local production and related technology transfer as a strategy to promote innovation, build capacity and improve access to quality-assured medical products.

Many countries, particularly LMICs, need guidance and support to strengthen coherent policies and a conducive business environment, as well as for local production to be quality assured and sustainable. Requested by Member States, the LPA Unit has been providing holistic and coordinated support across the value chain – from R&D and product development to technology transfer and manufacturing to distribution, supply, etc. – to strengthen local production and technology transfer in collaboration with UN agencies and other partners under WHA61.21, WHA71(8), WHA72.8, WHA74.6 and others. This includes guidance tools, situational analyses for sustainable quality local production, fostering partnerships to seek consensus and a global approach in strengthening local production, capacity building and PQ/EUL/ERP(D)-related specialized technical assistance to achieve quality assurance and sustainability, development of skilled human resources, risk-based product selection, and facilitating technology transfer for prioritized products and technologies.

Local Production

The LPA Unit supports Member States in strengthening sustainable local production ecosystem-wide and across the value chain by forging political commitment through strategies, policies and partnerships; providing country support and Technology transfer, building capacity of manufacturers, regulators and other stakeholders, and providing assistance on Prequalification (PQ) related topics.

Low- and middle-income countries’ (LMICs) need for quality assured medicines and health products is dependent on importation and are at risk of inconsistent supply of such products. LMICs are increasingly interested in developing the local production of their own quality-assured medicines and health products. Hence, local production is a strategy to improve access to safe, quality-assured, affordable medical products, ensure reliable supply chains, achieve universal health coverage, strengthen health security, and reach the health-related targets and broader development goals of the SDGs.

Technology Transfer

Technology transfer is a logical procedure that controls the transfer of products, processes and knowledge together with its documentation and professional expertise, allowing the diffusion of innovation to new horizons/markets. Technology transfer can build capacity for quality local production in a relatively short time and bring the supply of essential health products closer to the public health needs.

Manufacturers, particularly in LMICs, may face challenges accessing and implementing the technology to build capacity. Technology transfer is a complex process that needs a holistic and collaborative approach. The LPA Unit supports countries to facilitate technology transfer fand absorption for sustainable quality local production with a focus on priority health products or technologies which have high public health impact, in collaboration with other WHO programmes. The LPA Unit, for example, conducts landscape analyses on technology transfer for the local production of medical products, and continuously explores mechanisms to increase technology transfer and new opportunities for collaboration to promote technology transfer in developing countries in line with country needs.

Initiatives

A community of the foremost leaders, technology experts, industry, international organizations and other stakeholders under the auspices of WHO for public health impact.

The WHO Biomanufacturing Workforce Training Initiative supports countries to develop the workforce for biomanufacturing, leveraging on the Global Training Hub for Biomanufacturing, existing capacity building activities within WHO, and a network of regional training centers.

Technical Advisory Group on Local Production and Technology Transfer of Health Products

Learn more >

Open Surveys

News

All →

23 May 2025

Departmental update

3rd World Local Production Forum ends with strong call for health equity, security, and sustainability

19 November 2024

Departmental update

Countries in the Western Pacific Region are building capacity to achieve conducive ecosystems for sustainable local production

11 May 2025

Departmental update

WHO adds Serbia to its series of country case studies on local production ecosystems for pharmaceuticals, vaccines, and biologicals

10 October 2024

Departmental update

WHO’s 5th Virtual cGMP Training Marathon concludes, strengthening global vaccine manufacturing capacities

13 January 2025

Departmental update

Host Country Agreement signing ceremony for the 3rd World Local Production Forum held in Abu Dhabi

29 May 2024

Departmental update

Advancing biomanufacturing workforce training for global health equity - Key takeaways and future directions

26 November 2024

Departmental update

Join the global effort in strengthening local production for health equity and security: The 3rd World Local Production Forum will be held in the United Arab Emirates in 2025

Events

All →

WHO’s sixth Virtual cGMP Training Marathon launches to strengthen global local production foundations

9 September – 2 October 2025

Week of Quality for Vaccines and Biotherapeutic Products 2025: Registration Now Open

24 – 26 June 2025

Week of Quality for In Vitro Diagnostics 2025: Registration Now Open

3 – 5 June 2025

Week of Quality for Medicines 2025: Registration Now Open

26 – 28 May 2025

Strengthening Vaccine Manufacturing: Announcing the Fifth Virtual cGMP Training Marathon - Institutionalizing Compliance and Continued Improvement

10 September – 10 October 2024

Multimedia

All →

30 November 2023

Opening of the World Local Production Forum with Dr Tedros

30 May 2019

Local Production of Medicines - Technical Briefing at WHA72

Resolutions

WHA74.6 Strengthening local production of medicines and other health technologies to improve access

Report by the Director-General

Download

Report by the Director-General

Download

Addressing the global shortage of, and access to, medicines and vaccines

In January 2018, the Executive Board, at its 142nd session, noted an earlier version of this report1 and adopted decision EB142(3) in which it recommended...

Download

Global strategy and plan of action on public health, innovation and intellectual property - WHA68.18

Global strategy and plan of action on public health, innovation and intellectual property. The Sixty-eighth World Health Assembly.

Download