Mexico’s COFEPRIS establishes new electronic Appointment System
From September,1st 2020 COFEPRIS establishes the request for appointments will be via the internet and face-to-face attention in the CIS for the entry of priority formalities.
Mexico’s COFEPRIS promotes the production of generic drugs with new operating rules
COFEPRIS establishes operating rules to promote the production of generic drugs in Mexico, by eliminating criteria that limited their production and their availability at more accessible prices for the population.
Face Mask Regulations by Australia’s TGA
Non-sterile face masks are regulated as medical devices under the Therapeutic Goods Act of 1989. Importation, distribution or exportation of any goods are required to be included in the ARTG (Australian Register of Therapeutic Goods).
Face Mask Regulations by Australia’s TGA
Non-sterile face masks are regulated as medical devices under the Therapeutic Goods Act of 1989. Importation, distribution or exportation of any goods are required to be included in the ARTG (Australian Register of Therapeutic Goods).
Australia’s TGA regulations for cosmetics with sunscreens
In Australia, cosmetics that contain sunscreens (UV filters) are regulated by the Health Authority Therapeutic Goods Administration (TGA). The cosmetic can only be approved for market if it meets the legal definition of either ‘therapeutic’ or ‘cosmetic’.
FDA introduces Medical Device User Fee Amendments for Fiscal year 2021
Food and Drug Administration updates lists of Medical Device User Fees for Fiscal year 2021. and increases cost of certain MD submissions.
Brazil’s Health Authority requires Registration Holders to send daily information to ANVISA regarding drugs necessary in COVID-19 Pandemic
Companies that hold drug registrations must provide Anvisa daily information about the manufacture, import and distribution of anesthetics, sedatives, neuromuscular blockers and adjuvant agents, among other drugs used to maintain the lives of patients infected with the new coronavirus (Sars-CoV-2).
FDA fills in the details with guidance for Marketing Status Notification
In 2017, the Reauthorization Act (FDARA) made it mandatory for drug marketing holders to notify the FDA about the status of the NDA or ANDA product withdrawal. The FDA releases guidance on how to update the FDA appropriately.
Good Manufacturing Practices Certificate (CBPF) Renewal with Brazil’s Anvisa
Every Two years in Brazil, Manufactures must renew their GMP certificate known as CBPF, incorrect petition of this renewal will lead to rejection or return.
The UK’s MHRA provides more provisions on Pharmacovigilance
UK MHRA publishes UK, (12A) to Regulation 205A, providing provisions for pharmacovigilance activities and PMSF requirements.
Whitening Cosmetics: Regulatory Requirements in China
Freckle and whitening cosmetics are mainly used to reduce skin epidermal pigmentation or help skin whitening and whitening. New regulation have been implement to have ore over site of cosmetic products and prevent serious adverse effects.
US FDA releases draft guidance for Cannabis and Cannabis- derived Compounds used in Clinical Research
The US FDA released a new guidance on July 2020 on the clinical research and development of drugs containing cannabis or cannabis derived compounds.