EU-Israel Pact Recognizes Shared GMP Standards, Inspection Procedures
The EU and Israel have aligned their good manufacturing practice (GMP) standards and procedures for drug products and plant inspections, the European Medicines Agency (EMA) says.
The agreement on conformity assessment and acceptance (ACAA) allows EU-certified drugs to be exported to Israel and vice-versa without requiring additional certification for the importing country. The accord is intended to cut manufacturers’ costs and bring products to market faster.
The deal applies to finished drugs, active pharmaceutical ingredients and excipients. It does not apply to INDs, homeopathic drugs or special products based on human tissues, blood and cells.
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