Pharmaceutical Industry News

Analysis of regulation, quality, innovation, market and trends in Europe and Latin America.
GMP and AIM inspection Italy

Update the means of requesting GMP Inspection and AIM from Italy

Companies request that paper measures be sent by registered mail to the GMP Inspections and Authorizations Office....
AEMPS Allergenic Medicines

AEMPS publishes resolution on Allergenic Medicines

AEMPS sets specific deadlines and publishes a list of allergenic medicines for authorization and marketing....
Consensus Statement on Medical Devices

EU publishes ‘Consensus Statement’ on Medical Devices

The consensus statement on the EU medical devices regulation receives approval from the National Competent Authorities, including INFARMED....
cannabis medicinal que passa a estar disponível em Portugal

Infarmed approves two new ACMs for cannabis formulas

Infarmed approves Satalliv and Tilray and increases the number of medicinal cannabis preparations available in Portugal to six....
Medicamento nasal para emergências anafiláticas

First nasal medication to treat anaphylactic reactions

The EMA approves Eurneffy, the first nasal medicine for anaphylactic emergencies, through the Committee for Medicinal Products for Human Use....
Medicamentos que são aprovados pela EMA

EMA proposes approval of 10 new drugs

The EMA recommends the approval of 10 new drugs, highlighting Balversa and Eurneffy for emerging therapeutic innovations....

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