One of the top Indian multinational companies has been selling an antihistamine in the UK as Prescription Only Medicine (POM). DDReg was assigned with the task to assess the feasibility of change in the legal status of the product and thereafter support the regulatory strategy by way of developing safety rationale with regulatory documentation in […]
POM to P & GSL Switch – First Time for Molecule Read More »
Agencies across the emerging markets have been dealing with lot of ambiguities pertaining to Active Substance. These ambiguities emanate when a number of applicants submit diverse active substance information or Drug Master files (DMFs) on the same active by the same Active supplier (DMF Source). This usually happens when each applicant asks the API supplier
Development of all-inclusive “Global” DMF Read More »
Biosimilar Market Authorization in Malaysia Unlike most small-molecule drugs, which are chemically synthesized with highly predictable structures and functions, biologics and biosimilars are pharmaceutical compounds synthesized or extracted from a biological source, often with much more complex structures. Thus, unlike generic medicines in which the active ingredients are identical to the reference small-molecule drug, biosimilars
Biosimilar Market Authorization in Malaysia Read More »
A UK-based global CHC organization wanted to seek MA for a Fixed Dose Combination analgesic formulation. The product was sourced from a 3rd party CMO. Usually, the 3rd party sourcing is required when the in-house pipeline not able to support markets or when there is a local/regional business need for a client. For getting a
UK registration of a formulation of a big global brand, sourced from 3rd party CMO Read More »
