7/13付でEMAからICH Q4B（局方関係）の各種Annexes（各条に相当）がアップデートされています。
関係者にあっては、下記Annexesをご参照ください。
●ICH guideline Q4B Annex 1 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on residue on ignition/sulphated ash - Step 5, adopted (updated)
●ICH guideline Q4B annex 2 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter - Step 5, adopted (updated)
●ICH guideline Q4B Annex 3 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination: sub-visible particles general chapter - Step 5, adopted (updated)
●ICH guideline Q4B Annex 4A on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micro enumeration - Step 5, adopted(updated)
●ICH guideline Q4B Annex 4B on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Tests for specified micro-organisms - Step 5, adopted (updated)
●ICH guideline Q4B Annex 4C on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use - Step 5, adopted (updated)
●ICH guideline Q4B Annex 5 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on disintegration test - general chapter - Step 5, adopted (updated)
●ICH guideline Q4B Annex 8 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions sterility test - general chapter - Step 5, adopted (updated)
●ICH guideline Q4B Annex 9 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on tablet friability - general chapter - Step 5, adopted (updated)
●ICH guideline Q4B Annex 10 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on polyacrylamide gel electrophoresis - general chapter - Step 5, adopted (updated)
ちなみに、日本でのこれらAnnexesについては、Step 5として施行されています。
2016年11月11日現在の進捗状況については、下記URLの進捗状況一覧をご参照ください。
http://www.pmda.go.jp/files/000215512.pdf
関係者にあっては、下記Annexesをご参照ください。
●ICH guideline Q4B Annex 1 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on residue on ignition/sulphated ash - Step 5, adopted (updated)
●ICH guideline Q4B annex 2 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter - Step 5, adopted (updated)
●ICH guideline Q4B Annex 3 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination: sub-visible particles general chapter - Step 5, adopted (updated)
●ICH guideline Q4B Annex 4A on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micro enumeration - Step 5, adopted(updated)
●ICH guideline Q4B Annex 4B on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Tests for specified micro-organisms - Step 5, adopted (updated)
●ICH guideline Q4B Annex 4C on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use - Step 5, adopted (updated)
●ICH guideline Q4B Annex 5 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on disintegration test - general chapter - Step 5, adopted (updated)
●ICH guideline Q4B Annex 8 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions sterility test - general chapter - Step 5, adopted (updated)
●ICH guideline Q4B Annex 9 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on tablet friability - general chapter - Step 5, adopted (updated)
●ICH guideline Q4B Annex 10 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on polyacrylamide gel electrophoresis - general chapter - Step 5, adopted (updated)
ちなみに、日本でのこれらAnnexesについては、Step 5として施行されています。
2016年11月11日現在の進捗状況については、下記URLの
http://www.pmda.go.jp/files/
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