Pharmacovigilance is a tool proposed during the post-marketing process of the pharmaceutical product lifecycle to monitor drug safety in everyday life and to identify adverse drug reactions. The identification of adverse reactions, however, is a significant cause of concern and a challenge to pharmacovigilance structures. Regulators use three basic principles in determining the risk-benefit balance to decide whether to approve a drug or a biological product and to maintain it on the market: safety, quality and effectiveness. In particular, paediatric patients, especially new-borns and infants, are at risk of drug-related adverse reactions. Drugs are also prescribed in an unlicensed and/or off-label manner to new-borns, infants and teenagers, leading paediatric patients to a higher risk of experiencing adverse drug reactions (ADRs). ADRs in children < 2 years of age are often reported and can often be alarming. The practise of paediatric pharmacovigilance needs to be strengthened by stimulating spontaneous paediatric reporting and successful post-marketing surveillance. The current study highlights the importance of paediatric pharmacovigilance and the role of different stakeholders like healthcare providers, regulators, and consumers in increasing the ADR reporting rate. Also, it discusses the pharmacovigilance tools and various initiatives that are taken by various regulatory authorities like the United States, the United Kingdom, Japan, and India.
The goal of cosmetics regulation is to provide Sri Lankans with safe and high-quality cosmetics that are equivalent to those in other nations. To accomplish these regulators and industry should collaborate to achieve common objectives. This category includes skin creams, lotions, perfumes, lipsticks, nail polishes, and eye and lip cosmetics. Face makeup, shampoos, permanent waves, hair colours, teeth pastes, deodorants, and any other cosmetics Ingredient intended for use in cosmetic items and gadgets, soap making Cosmetics that do not state that they are for human use are not considered cosmetics under the law. According to the Sri Lankan government, cosmetics must be registered before they can be manufactured, supplied, distributed, or sold. The regulations' goal is to provide guidance and inform marketing authorization holders and consumers about the regulatory authorities' procedures and criteria for determining aesthetic suitability, as well as the requirements for registration and how applications should be made, and how to import, manufacture, distribute, and sell cosmetics in Sri Lanka [NMRA].
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