The State Administration for Market Regulation ("SAMR") has recently issued the Administrative Measures for Drug Registration and the Measures for Supervision and Administration of Pharmaceutical Production (collectively as the "Measures"), with effect from July 1, 2020.
Compared with the previous edition, the Measures incorporate principal changes in four aspects: 1. putting in place the drug marketing authorization holder system; 2. optimizing the work procedures for reviews, examination and approval; 3. fulfilling life-circle management requirements; and 4. intensifying accountability. Among others, the Measures call for ensuring a smooth connection between different steps, such as acceptance of drug registration applications, reviews, verification, and inspections, stating that the reviews, verification and inspections which used to be performed in sequence will be performed in parallel; it also introduces four fast tracks for ground-breaking therapeutic drugs, conditional approval, prioritized reviews and examination and approval, and special examination and approval, clearly defines the time limit for reviews, and improves the efficiency of drug registration and the expectation for registration timeframe. Meanwhile, under the principle of risk management, changes will be administered by category, as required by the reform of "delegating power, streamlining administration and strengthening regulation, and improving services". Furthermore, the Measures provide more details about the circumstances of punishment, and stipulate severe crackdown upon such violations as data falsification.