إجراء مقترح من اليابان: منتجات صيدلة

The Minimum Requirements for Biological Products will be amended as follows: ・Regarding the standard for 'Recombinant Adsorbed Hepatitis B Vaccine (Prepared from Yeast)', 'Tests on vector and inserted gene' will be amended to 'Tests on inserted gene'. ・Regarding the standard for 'Freeze-dried Live Attenuated Rubella Vaccine', a test by Reverse Transcription Polymerase Chain Reaction (RT-PCR) may be used for the Identification Test. ・Regarding the standard for 'Freeze-dried Live Attenuated Measles Vaccine', a test by RT-PCR may be used for the Test for freedom from extraneous viruses and the Identification Test. ・In addition, regarding the standard for 'Freeze-dried Live Attenuated Measles-Rubella Combined Vaccine', a test by RT-PCR may be used for the Confirmation of the labeling.