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TEXT I

FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

 Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor). 

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-unresectable-or-metastatic-melanoma

TEXT II

Update on MHRA safety review of medicines containing pseudoephedrine

The MHRA has reviewed the latest evidence relating to the very rare risk of PRES and RCVS associated with medicines containing pseudoephedrine

Pseudoephedrine is licensed for the symptomatic relief of nasal and sinus congestion in colds, flu, and allergies. It has been used in the UK for decades by millions of people. All pseudoephedrine-containing medicines in the UK are for short term use and taken orally. These come in tablet, capsule, powder, liquid, or syrup form; none of the decongestant nasal sprays authorised in the UK contain pseudoephedrine.

There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with pseudoephedrine. These are very rare conditions that can involve inflammation and/or reduced blood supply to the brain, which are recognised as very rare side effects for pseudoephedrine-containing medicines licensed in the UK.

Following a careful MHRA review of the latest available evidence, including the assessment of cumulative reporting of adverse drug reaction reports, the safety information of all pseudoephedrine-containing medicines will be updated to provide clearer descriptions of these risks and potential risk factors for these conditions for both patients and healthcare professionals.

Source: https://www.gov.uk/government/news/update-on-mhra-safety-review-of-medicines-containing-pseudoephedrine

TEXT III

The role of sanitation regulatory agencies and service providers in spring conservation for water security

This document discusses the conceptual and legal aspects of the role of the sanitation sector in spring protection. Designed under the Brazilian legal framework, its purpose is to serve as a benchmark for other countries willing to promote the sanitation sector leadership to protect their source waters. Supplying drinking water involves primarily obtaining water from a body such as a river, lake, reservoir, or groundwater source. Therefore, it depends essentially on the quality of the source. The arguments presented here aim to promote long-term water security and support the investment of water utilities in conserving water sources via funds from water tariffs.

Source: https://www.tnc.org.br/content/dam/tnc/nature/en/documents/brasil/tnc-papeldasreguladorasagua2021-eng.pdf

After reading the above texts and, in light of them, write a 30-line essay on the importance of regulatory agencies for governments worldwide. In your text, approach the following topics:

• the definition of regulatory agencies;
• the many areas in which they act, along with examples, especially within the Brazilian Government.