Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to
...
understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
more
• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate their appropriate use in Member States;
• provide models to assist Member
...
States in developing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
more
The occurrence of a high percentage of couterfeit medicines on the global medicines market is often attributed to a lack of effective regulation and a weak enforcement capacity. This review, while focusing on counterfeit medicines and medical devices in developing countries, will present information
...
on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world.
more
This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.
Drug Distribution and Control: Preparation and Handling
This Technical Assistance Bulletin is intended to assist pharmacists in the extemporaneous compounding of non-sterile drug products for individual patients. Included in this document is information on facilities and equipment, ingredient
...
selection, training, documentation and record keeping, stability and beyond-use dating, packaging and labeling, and limited batch compounding. This document is not intended for manufacturers or licensed repackagers.
more
An Indicator-based Approach - This manual presents an indicator-based approach for rapidly assessing pharmaceutical management systems and programs. The manual contains a set of 46 indicators of performance, grouped under eight topics of pharmaceutical management, with each topic being covered by a
...
subset of indicators. Thirty-four of the indicators are quantitative, that is, expressed as numbers. Twelve are qualitative, in that they describe the presence or absence of a policy or management system, and in some cases, the degree of implementation.
more
The framework is to be used as a reference guide, applied according to local priorities and needs, and targeted at academic institutions, educators, accreditation bodies, regulatory agencies and other users. The ultimate aim is to ensure that all health workers are equipped with the requisite compet
...
encies at pre-service education and in-service training levels to address AMR in policy and practice settings.
more
Two test methods on dexamethasone tablets and injections