国内法规没有要求。FDA及EMA、ICH要求检外源因子：

具体可以看看这一篇——>国内外生物技术产品病毒安全控制对比

• FDA：Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals
  

The unprocessed bulk is the pooled harvests of cell culture fluids that constitutes a homogeneous mixture for manufacture into a unique lot of product. It is important that testing for adventitious agents be performed prior to further processing such as filtration, clarification or other procedures, unless such testing is made more sensitive by initial partial processing (e.g., unprocessed bulk may be toxic in test cell cultures, whereas filtered bulk may not). 未加工收获液（UPB）在进一步加工（如过滤、澄清等）之前应进行外源因子的检定。　

• EMA：Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products
  

Independent of the stage of development, each batch of unprocessed bulk material that will be used to manufacture clinical trial material should be tested as per Q5A. The sample to be tested should include cells, when appropriate, and tests should include in vitro and PCR-based screening tests for adventitious agents and an estimation of retroviral particles, where applicable. 独立于开发阶段，在临床试验期间应对每一批涉及临床试验样品制备的UPB按照ICH Q5A进行外源因子的检定。

^*Where possible, test material should contain cells or cellular fragments in order to detect cellassociated viruses. For perfusion cell cultures, manufacturers should determine and justify the most appropriate stage at which to derive samples containing cells for testing. It is also acceptable to derive test material from cells that have been cultured beyond the scale used to generate the batch of product; in these circumstances, the approach taken should be justified. Testing for infectious retroviruses may be omitted when more sensitive tests have shown negative results.
^§ Quantification of retroviruses or retroviral-like particles need only be performed for the first three bulks for a specific stage of development (or less, if less than three bulks are prepared).

• ICH：Q5A (R1) 中译
  

未加工收获液在深加工前，均应进行病毒测试，除非部分初加工后的样品对病毒测试更敏感（如未加工品在细胞培养物中可能有毒性，而经部分加工后可能就没有毒性了）。在进行上市注册申请时，至少应提供3批次商业化规模未加工收获液（UPB）的外源因子研究结果。