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FIP Library

FIP makes it a priority to publish the latest developments in pharmacy practice, pharmaceutical sciences, related global news and prominent events. Our multi-media approach to keeping members, partners and peers informed of what is and will be affecting their area of practice or science is key to keeping information flowing through the FIP network.

FIP makes it a priority to publish the latest developments in pharmacy practice, pharmaceutical sciences, related global news and prominent events. Our multi-media approach to keeping members, partners and peers informed of what is and will be affecting their area of practice or science is key to keeping information flowing through the FIP network.

Lastest Publications

2025Investigational drug container and carton labelling: Yearning for improvement

Clinical trials are conducted with investigational drugs to collect data to support their approval for treatment of certain diseases or medical conditions. In the rigorous milieu of clinical trials, sponsors, scientists, and clinicians scrutinise the safety and efficacy of the investigational drug and meticulously assess the product manufacturing process. Unlike the labelling of FDA-approved marketed products, there is limited regulatory oversight to guide, standardise, and govern container label and carton labelling for investigational (i.e., not-yet-approved) drugs (hereafter referred to as ‘investigational drug labelling’). This lack of standardisation may lead to medication errors, harm to the research participants, and compromise data integrity, which are concerns raised by stakeholders in the past. To address the suboptimal information in the investigational drug labelling, a renewed focus on raising awareness and developing standardised labelling practices is needed. Interim solutions and long-term strategies must be considered to improve patient safety and preserve the integrity of trial data. Collaborative efforts among sponsors, clinical site investigators, and regulators are crucial for achieving a consensus on best practices for investigational drug labelling to improve patient safety and study outcomes during clinical trials.
Authors

CDR Katherine S. Won, PharmD, MBA, BCSCP, US Food and Drug Administration
Silver Spring, MD, USA

LT Jing Tassone, PharmD, Clinical Center, Pharmacy, National Institutes of Health, Bethesda, MD, USA

CAPT Haksong Jin, PharmD, MS, BCSCP, Therapeutic Development Branch, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD, USA

2025Harmonisation of clinical studies in the Asia-Pacific Region: A summary of a recent forum

The Asia-Pacific region has rapidly emerged as a major hub for global clinical trials, offering diverse patient populations and growing research capacity. However, differences in national regulations and procedures highlight an urgent need for greater collaboration and harmonisation. A recent regional forum in Taipei, Taiwan, brought together regulators, academics, and industry leaders to address these challenges and promote cross-country mutual recognition of clinical data.

As reported by: Finny Liu[1], Oliver Yoa-Pu Hu[2][3][4][5]*


[1] PDR APAC Regional Regulatory Policy Lead, Roche Singapore Pte Ltd

[2] Co-Chair of SIG, FIP and Organize Committee Chairman of “Harmonization of Clinical Studies Among the Asia-Pacific Region: Including Bridging Studies” Forum, July 28-29, 2025, Taipei, Taiwan.

[3] Chair professor of Taipei Medical University

[4]Honorary professor of National Defense Medical University

[5] Honorary President of Chinese Life Technological Law Society


2025Antimicrobial stewardship programmes in the hospital setting: Global policies and practices

The FIP Global Pharmaceutical Observatory (GPO) is a worldwide data hub to inform the advocacy work of our members and partners.  

The FIP Atlas is a platform being developed to showcase our members’ needs and priorities (supported by the data from the GPO), allowing us to identify opportunities for developing pharmacy with, for and through our member organisations.  

Latest intelligence and data on the state of pharmacy and pharmaceutical science around the world.  

 



Last update 28 March 2022

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