On 20 June 2022, the new national pharmacovigilance network, which ensures the collection, management and analysis of suspected adverse reaction reports of medicines in Italy, became operative.
The MHRA has been accepted as a full member of three groups: the International Medical Device Regulatory Forum (IMDRF), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the US-based Medical Devices Innovation Consortium. These partnerships bolster the MHRA’s position as an influential international player in medicinal and medical device regulation and restore the MHRA’s ties with the IMDRF and ICH.
Following the public consultation held in late 2021 on proposed changes to the Malaysian Communications and Multimedia Content Code (“Content Code”), the Communications and Multimedia Content Forum of Malaysia has now issued the revamped version of the Content Code effective from 30 May 2022.
In the wake of last month’s collapse of the TerraUSD token, a broad array of regulators and government officials have attempted to introduce a legal framework around stablecoins. Last week, Senators Lummis and Gillibrand introduced a bill into the US Congress that would, among other things set requirements for the amount of backing assets stablecoin issuers would be required to hold.
Following the issuance of the notification from the Ministry of Public Health regarding determination of category V narcotics, B.E. 2565 (2022), the Thai Food and Drug Administration has recently provided guidelines.
The Spanish Agency for Medicinal Products and Medical Devices has launched a new application with the aim of facilitating the registration and improving the communication of biocidal products and of personal care products, as well as regarding facilities that manufacture, import and store biocidal products within the Spanish territory.
In April 2022, the Health Sciences Authority published its revised Regulatory Guidelines for Software Medical Devices. It has also finalised its new Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Software, which had been released for public consultation in July to August 2021.
On 2 June 2022, ASIC published the updated ePayments Code which it states will strengthen and clarify a number of existing protections for consumers relating to various forms of electronic payments. The Code has generally been the benchmark for consumer protections for payments and transactions that were triggered within the world of online and mobile banking. It has been an added level of regulation for its subscribers which include most banks, credit unions and building societies in Australia.
Law No. 31435 was published on 22 March 2022, amending the Consumer Protection and Defense Code which modifies the deadlines for handling consumer protection claims.
By means of Resolution 464/2022 published on the Official Gazette on 27 May 2022, the domestic trade secretariat approved the form that suppliers must submit to alert consumers and competent authorities and recall products from the market. It also establishes certain obligations that suppliers that have initiated this type of process must comply with.